Back to resultsBioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions
Primary Purpose
Gastrointestinal Diseases
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
IDIAZOLE 20mg DR tabs
PARIET 20 mg DR tabs
Sponsored by
About this trial
This is an interventional other trial for Gastrointestinal Diseases focused on measuring Bioequivalence, Fed condition, PARIET 20 mg, IDIAZOLE 20mg, Rabeprazole
Eligibility Criteria
Inclusion Criteria:
- Healthy male or female, age 18 to 55 years, inclusive.
- Body weight within 10 percent of normal range according to the accepted normal values for body mass index (BMI).
- Medical demographics without evidence of clinically significant deviation from normal medical condition.
- Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
- Subject does not have allergy to the drugs under investigation.
Exclusion Criteria:
- Subjects with known allergy to the products tested.
- Subjects whose values of BMI were outside the accepted normal ranges.
- Female subjects who were pregnant, nursing or taking birth control pills.
- Medical demographics with evidence of clinically significant deviation from normal medical condition.
- Results of laboratory tests which are clinically significant.
- Acute infection within one week preceding first study drug administration.
- History of drug or alcohol abuse.
- Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
- Subject is on a special diet (for example subject is vegetarian).
- Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
- Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
- Subject has a history of severe diseases which have direct impact on the study.
- Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
- Subject intends to be hospitalized within 6 weeks after first study drug administration.
- Subjects who, through completion of this study, would have donated more than 500 milliliter (mL) of blood in 7 days, or 750 mL of blood in 30 days, 1000 mL in 90 days, 1250 mL in 120 days, 1500 ml in 180 days, 2000 mL in 270 days, 2500 mL of blood in 1 year.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A-Idiazole then Pariet
Group B-Pariet then Idiazole
Arm Description
Subjects will receive a single oral dose of IDIAZOLE 20mg DR tabs under fed condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of PARIET 20 mg DR tabs under fed condition in treatment period 2.
Subjects will receive a single oral dose of PARIET 20 mg DR tabs under fed condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of Idiazole 20mg DR tabs under fed condition in treatment period 2.
Outcomes
Primary Outcome Measures
Maximal Measured Plasma Concentration (Cmax) of Rabeprazole
Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. The Cmax was computed directly from measured data.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC [0-t]) of Rabeprazole
Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. AUC (0-t) was calculated from measured data points from time of administration to time of last quantifiable concentration (Clast) by the linear trapezoidal rule.
Mean Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC [0 to Infinity]) of Rabeprazole
Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods.
Secondary Outcome Measures
Mean Time to the Maximum Plasma Concentration (Tmax) of Rabeprazole
Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Tmax was computed directly from the measured data.
Mean Apparent First-order Elimination or Terminal Rate Constant (Ke) of Rabeprazole
Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Ke was derived from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.
Mean Terminal Half Life (t1/2) of Rabeprazole
Half life is the period of time required for the concentration or amount of drug in the body to be reduced by one-half. Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. t1/2 was calculated as: t1/2 = Ln(2) / (-b), where b was obtained as the slope of the linear regression of the Ln-transformed plasma concentrations versus time in the terminal period of the plasma curve.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02605395
Brief Title
Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions
Official Title
Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Rabeprazole From Raperazole 20mg DR Tabs (GSK, Egypt) and PARIET 20 mg DR Tabs (JANSSEN, EGYPT) After a Single Oral Dose Administration of Each to Healthy Adults Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 22, 2014 (Actual)
Primary Completion Date
March 30, 2014 (Actual)
Study Completion Date
March 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open-label, randomized, single dose, two-sequence, two-periods crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each to healthy adults fed under conditions.
In Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.
PARIET is a registered trademark of EISAI Co. Limited.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Diseases
Keywords
Bioequivalence, Fed condition, PARIET 20 mg, IDIAZOLE 20mg, Rabeprazole
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A-Idiazole then Pariet
Arm Type
Experimental
Arm Description
Subjects will receive a single oral dose of IDIAZOLE 20mg DR tabs under fed condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of PARIET 20 mg DR tabs under fed condition in treatment period 2.
Arm Title
Group B-Pariet then Idiazole
Arm Type
Experimental
Arm Description
Subjects will receive a single oral dose of PARIET 20 mg DR tabs under fed condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of Idiazole 20mg DR tabs under fed condition in treatment period 2.
Intervention Type
Drug
Intervention Name(s)
IDIAZOLE 20mg DR tabs
Intervention Description
IDIAZOLE 20mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.
Intervention Type
Drug
Intervention Name(s)
PARIET 20 mg DR tabs
Intervention Description
PARIET 20 mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg rabeprazole sodium.
Primary Outcome Measure Information:
Title
Maximal Measured Plasma Concentration (Cmax) of Rabeprazole
Description
Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. The Cmax was computed directly from measured data.
Time Frame
Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2
Title
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC [0-t]) of Rabeprazole
Description
Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. AUC (0-t) was calculated from measured data points from time of administration to time of last quantifiable concentration (Clast) by the linear trapezoidal rule.
Time Frame
Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2
Title
Mean Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC [0 to Infinity]) of Rabeprazole
Description
Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods.
Time Frame
Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2
Secondary Outcome Measure Information:
Title
Mean Time to the Maximum Plasma Concentration (Tmax) of Rabeprazole
Description
Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Tmax was computed directly from the measured data.
Time Frame
Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2
Title
Mean Apparent First-order Elimination or Terminal Rate Constant (Ke) of Rabeprazole
Description
Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Ke was derived from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.
Time Frame
Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2
Title
Mean Terminal Half Life (t1/2) of Rabeprazole
Description
Half life is the period of time required for the concentration or amount of drug in the body to be reduced by one-half. Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. t1/2 was calculated as: t1/2 = Ln(2) / (-b), where b was obtained as the slope of the linear regression of the Ln-transformed plasma concentrations versus time in the terminal period of the plasma curve.
Time Frame
Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male or female, age 18 to 55 years, inclusive.
Body weight within 10 percent of normal range according to the accepted normal values for body mass index (BMI).
Medical demographics without evidence of clinically significant deviation from normal medical condition.
Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
Subject does not have allergy to the drugs under investigation.
Exclusion Criteria:
Subjects with known allergy to the products tested.
Subjects whose values of BMI were outside the accepted normal ranges.
Female subjects who were pregnant, nursing or taking birth control pills.
Medical demographics with evidence of clinically significant deviation from normal medical condition.
Results of laboratory tests which are clinically significant.
Acute infection within one week preceding first study drug administration.
History of drug or alcohol abuse.
Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
Subject is on a special diet (for example subject is vegetarian).
Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
Subject has a history of severe diseases which have direct impact on the study.
Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
Subject intends to be hospitalized within 6 weeks after first study drug administration.
Subjects who, through completion of this study, would have donated more than 500 milliliter (mL) of blood in 7 days, or 750 mL of blood in 30 days, 1000 mL in 90 days, 1250 mL in 120 days, 1500 ml in 180 days, 2000 mL in 270 days, 2500 mL of blood in 1 year.
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
Cairo
Country
Egypt
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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
201528
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
201528
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
201528
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
201528
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions
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