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Comparative Bioavailability Study of Two Test Products of Fixed Dose Combination Capsule of Acetylsalicylic Acid (ASA) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Under Fed Conditions

Primary Purpose

Ulcers, Duodenal and Gastric

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one
Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two
ASA 100 mg tablet
Pantoprazole 20 mg gastro-resistant tablet
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcers, Duodenal and Gastric focused on measuring Acetylsalicylic acid, Pantoprazole, Fixed dose combination

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Healthy human subjects within the age range of 18 to 45 years (both inclusive)
  • Non-smokers since at least six months
  • Willingness to provide written informed consent to participate in the study
  • Body-mass index (BMI) of >=18.5 kilogram per meter square (kg/m^2) and <=24.9 kg/m^2, with body weight not less than 50 kg
  • Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening
  • Normal 12-lead ECG or one with abnormality considered to be clinically insignificant
  • Normal chest X-ray Posterior Anterior (PA) view
  • Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.
  • Willing to consume non-vegetarian, high fat breakfast prior to dosing.
  • Female Subject is eligible to participate if she is of non-childbearing potential (surgically sterile or post-menopausal for at least 1 year); or of child bearing potential practicing an acceptable method of birth control while in the study and for 14 days after the end of the study, as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence)
  • Male Subjects willing to use an approved form of birth control (a double barrier method like condom with spermicide or condom with diaphragm) while in the study and for 14 days after the end of the study, and agree not to donate sperm during this period.

Exclusion criteria:

  • Personal / family history/ past history of allergy or hypersensitivity to ASA or pantoprazole or related drugs
  • Any contraindication to anticoagulant therapy
  • History of sensitivity to heparin or heparin-induced thrombocytopenia
  • Past history of active gastric or duodenal ulcer or esophagitis
  • A history of cholecystectomy or biliary tract disease including increased liver function tests of known or unknown etiology
  • Subjects who have been diagnosed with Gilbert's syndrome (Elevated Liver Function Test (LFT)'s Serum Glutamate Oxaloacetate Transaminase/ Serum Glutamate Pyruvate Transaminase (SGOT/SGPT) + Bilirubin (total and direct))
  • Past history of anaphylaxis or angioedema
  • Any history of myopathy
  • Female subject not willing to use acceptable method of contraception from the date of screening until 14 days after the end of the study
  • Male subject not willing to use acceptable method of contraception from the date of screening until 14 days after the end of the study
  • Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g.congestive heart failure, hepatitis, pancreatitis etc.
  • Presence of any clinically significant abnormal values during screening e.g. significant abnormality of LFT, Renal (kidney) Function Test (RFT) etc.
  • Any cardiac, renal or liver impairment, any other organ or system impairment
  • History of seizure or psychiatric disorders
  • Presence of disease markers of human immuno deficiency virus (HIV) 1 and 2, and hepatitis B and C virus
  • History of significant alcohol consumption for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to check-in in each period and during the study [one drink is equal to one unit of alcohol [one glass wine, half pint beer, and one measure (one ounce) of spirit].
  • Presence of painful erythema, oedema, or ulceration in the oral cavity
  • Consumption of xanthine containing derivatives (coffee, tea, cola drinks, chocolate) within 48 hours before check-in of each period
  • Use of any recreational drug or a history of drug addiction
  • Participation in any clinical trial within the past 3 months
  • Inaccessibility of veins in left and right arm
  • Donation of blood [one unit or 330 millilitre (mL)] within 3 months prior to study check-in
  • History of use of any prescription drug therapy within four weeks or over-the-counter (OTC) drugs within two weeks prior to study check-in or repeated use of drugs within the last four weeks
  • History of unusual diet, for whatever reason, e.g. low sodium diet, for 7 days prior to check-in for all the three periods
  • History of consumption of grapefruit-containing food or drinks within 7 days prior to the study check-in for all the three periods
  • Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 7 days prior to the study check-in for all the three periods
  • Difficulty in swallowing solids like tablets/capsules
  • Systolic blood pressure below 100 millimetres of mercury (mm Hg) and above 138 mm Hg, diastolic blood pressure below 60 mm Hg and above 90 mmHg
  • Heart rate below 60 beats/minute and above 100 beats/minute
  • Temperature below 96.0 degree Fahrenheit (F) and above 98.6 degree F
  • Female volunteers demonstrating a positive test for pregnancy during screening or currently breastfeeding

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Overall Study Arm

Arm Description

All the subjects in this study will take part in 3 treatment periods with one of the following treatments in each period. Subjects will receive all three treatments (one per period) in a random order in fed condition. Test 1= Fixed dose combination (FDC) formulation one of a capsule containing ASA 100 mg and pantoprazole 20 mg. Test 2= FDC formulation two of a capsule containing ASA 100 mg and pantoprazole 20 mg. Reference= ASA 100 mg tablet + pantoprazole 20 mg gastro-resistant tablet

Outcomes

Primary Outcome Measures

Composite of pharmacokinetic (PK) parameters
The bioavailability of two test products was compared with the reference products after determining the plasma PK parameters: Cmax (maximum measured plasma concentration), Tmax (time of Cmax), AUC0-t (area under the plasma concentration versus time curve from time zero to the last measurable concentration), AUC0-infinity (AUC from zero to infinity), t1/2 (time required for the plasma drug concentration to decrease by one half), Kel (terminal rate constant) and AUC_% Extrap_Obs (residual area in percentage determined by formula) for ASA and pantoprazole in relevant treatments

Secondary Outcome Measures

Tolerability of combined ASA and pantoprazole in subjects during the study
Tolerability of combined ASA and pantoprazole in subjects during the study assessed by adverse events, laboratory tests, vital signs and ECG

Full Information

First Posted
May 2, 2013
Last Updated
July 10, 2017
Sponsor
GlaxoSmithKline
Collaborators
Piramal Clinical Research (Hyderabad, India)
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1. Study Identification

Unique Protocol Identification Number
NCT01847417
Brief Title
Comparative Bioavailability Study of Two Test Products of Fixed Dose Combination Capsule of Acetylsalicylic Acid (ASA) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Under Fed Conditions
Official Title
An Open Label, Balanced, Randomized, Three-treatment, Three-period, Six-sequence, Cross-over, Single Dose, Comparative Bioavailability Pilot Study of Two Test Formulations of Fixed Dose Combination Capsules of Acetylsalicylic Acid (ASA) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Manufactured by Piramal Healthcare Limited, India for GSK Comparing With Aspirin® Protect 100 mg Tablets by Bayer Vital GmbH, and Protium® 20 mg Gastro-resistant Tablets by Nycomed GmbH, in Healthy, Adult, Human Subjects, Under Fed Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 16, 2013 (Actual)
Primary Completion Date
July 1, 2013 (Actual)
Study Completion Date
July 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
Collaborators
Piramal Clinical Research (Hyderabad, India)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over, single dose, comparative bioavailability pilot study under fed conditions. For fed condition, after check-in, subjects will receive a standard dinner consisting (1000 - 1200 calories) after which they will be required to fast overnight (for at least 10 hours). Thereafter they will receive a non-vegetarian high calorie, high-fat breakfast (800-1000 calories) before dosing, and a standard meal (1700 - 1900 calories) for lunch, snacks and dinner.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcers, Duodenal and Gastric
Keywords
Acetylsalicylic acid, Pantoprazole, Fixed dose combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Overall Study Arm
Arm Type
Experimental
Arm Description
All the subjects in this study will take part in 3 treatment periods with one of the following treatments in each period. Subjects will receive all three treatments (one per period) in a random order in fed condition. Test 1= Fixed dose combination (FDC) formulation one of a capsule containing ASA 100 mg and pantoprazole 20 mg. Test 2= FDC formulation two of a capsule containing ASA 100 mg and pantoprazole 20 mg. Reference= ASA 100 mg tablet + pantoprazole 20 mg gastro-resistant tablet
Intervention Type
Drug
Intervention Name(s)
Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one
Intervention Description
Formulation Test 1 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK
Intervention Type
Drug
Intervention Name(s)
Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two
Intervention Description
Formulation Test 2 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK
Intervention Type
Drug
Intervention Name(s)
ASA 100 mg tablet
Intervention Description
Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg) manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany
Intervention Type
Drug
Intervention Name(s)
Pantoprazole 20 mg gastro-resistant tablet
Intervention Description
Protium® 20 mg gastro-resistant tablets (Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate)) marketing authorisation holder Nycomed GmbH, Byk-Gulden-Straβe 2, D-78467, Konstanz, Germany
Primary Outcome Measure Information:
Title
Composite of pharmacokinetic (PK) parameters
Description
The bioavailability of two test products was compared with the reference products after determining the plasma PK parameters: Cmax (maximum measured plasma concentration), Tmax (time of Cmax), AUC0-t (area under the plasma concentration versus time curve from time zero to the last measurable concentration), AUC0-infinity (AUC from zero to infinity), t1/2 (time required for the plasma drug concentration to decrease by one half), Kel (terminal rate constant) and AUC_% Extrap_Obs (residual area in percentage determined by formula) for ASA and pantoprazole in relevant treatments
Time Frame
During each period at pre-dose, 0.167, 0.333, 0.5, 0.667, 0.833, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 16 and 24 hrs post dose
Secondary Outcome Measure Information:
Title
Tolerability of combined ASA and pantoprazole in subjects during the study
Description
Tolerability of combined ASA and pantoprazole in subjects during the study assessed by adverse events, laboratory tests, vital signs and ECG
Time Frame
Up to 16 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Healthy human subjects within the age range of 18 to 45 years (both inclusive) Non-smokers since at least six months Willingness to provide written informed consent to participate in the study Body-mass index (BMI) of >=18.5 kilogram per meter square (kg/m^2) and <=24.9 kg/m^2, with body weight not less than 50 kg Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening Normal 12-lead ECG or one with abnormality considered to be clinically insignificant Normal chest X-ray Posterior Anterior (PA) view Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol. Willing to consume non-vegetarian, high fat breakfast prior to dosing. Female Subject is eligible to participate if she is of non-childbearing potential (surgically sterile or post-menopausal for at least 1 year); or of child bearing potential practicing an acceptable method of birth control while in the study and for 14 days after the end of the study, as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence) Male Subjects willing to use an approved form of birth control (a double barrier method like condom with spermicide or condom with diaphragm) while in the study and for 14 days after the end of the study, and agree not to donate sperm during this period. Exclusion criteria: Personal / family history/ past history of allergy or hypersensitivity to ASA or pantoprazole or related drugs Any contraindication to anticoagulant therapy History of sensitivity to heparin or heparin-induced thrombocytopenia Past history of active gastric or duodenal ulcer or esophagitis A history of cholecystectomy or biliary tract disease including increased liver function tests of known or unknown etiology Subjects who have been diagnosed with Gilbert's syndrome (Elevated Liver Function Test (LFT)'s Serum Glutamate Oxaloacetate Transaminase/ Serum Glutamate Pyruvate Transaminase (SGOT/SGPT) + Bilirubin (total and direct)) Past history of anaphylaxis or angioedema Any history of myopathy Female subject not willing to use acceptable method of contraception from the date of screening until 14 days after the end of the study Male subject not willing to use acceptable method of contraception from the date of screening until 14 days after the end of the study Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g.congestive heart failure, hepatitis, pancreatitis etc. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of LFT, Renal (kidney) Function Test (RFT) etc. Any cardiac, renal or liver impairment, any other organ or system impairment History of seizure or psychiatric disorders Presence of disease markers of human immuno deficiency virus (HIV) 1 and 2, and hepatitis B and C virus History of significant alcohol consumption for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to check-in in each period and during the study [one drink is equal to one unit of alcohol [one glass wine, half pint beer, and one measure (one ounce) of spirit]. Presence of painful erythema, oedema, or ulceration in the oral cavity Consumption of xanthine containing derivatives (coffee, tea, cola drinks, chocolate) within 48 hours before check-in of each period Use of any recreational drug or a history of drug addiction Participation in any clinical trial within the past 3 months Inaccessibility of veins in left and right arm Donation of blood [one unit or 330 millilitre (mL)] within 3 months prior to study check-in History of use of any prescription drug therapy within four weeks or over-the-counter (OTC) drugs within two weeks prior to study check-in or repeated use of drugs within the last four weeks History of unusual diet, for whatever reason, e.g. low sodium diet, for 7 days prior to check-in for all the three periods History of consumption of grapefruit-containing food or drinks within 7 days prior to the study check-in for all the three periods Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 7 days prior to the study check-in for all the three periods Difficulty in swallowing solids like tablets/capsules Systolic blood pressure below 100 millimetres of mercury (mm Hg) and above 138 mm Hg, diastolic blood pressure below 60 mm Hg and above 90 mmHg Heart rate below 60 beats/minute and above 100 beats/minute Temperature below 96.0 degree Fahrenheit (F) and above 98.6 degree F Female volunteers demonstrating a positive test for pregnancy during screening or currently breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Hyderabad
ZIP/Postal Code
500 013
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116498
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116498
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116498
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116498
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116498
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116498
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Comparative Bioavailability Study of Two Test Products of Fixed Dose Combination Capsule of Acetylsalicylic Acid (ASA) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Under Fed Conditions

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