Back to resultsBE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects
Primary Purpose
Gastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
D961H sachet 20 mg
D961H HPMC capsule 20 mg
Sponsored by
About this trial
This is an interventional basic science trial for Gastric Ulcer focused on measuring Bioequivalence, pharmacodynamics, pharmacokinetics, safety, tolerability, D961H, Japanese
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy Japanese male subjects between 20 and 45 years of age
- Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
- Body weight 50-85 kg
- Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis
- Clinically normal findings at the enrolment medical examination, as judged by the investigator(s)
- Homo-EM according to the genotype of CYP2C19
- Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording
- Helicobacter pylori negative has been known by urea breath test as the volunteer panel data
Exclusion Criteria:
- Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention
- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction
- Past or present drug addiction or alcohol abuse
- Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention
- Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use)
- Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach
- Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation)
- Need for concomitant medication in the study
- Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor
- Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1
- Administration of any investigational product within 4 months preceding the pre-entry visit
- Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site)
- Clinical judgment by the investigator(s) that the subject should not participate in the study
Sites / Locations
- Research Site
- Hakata Clinic Medical Co. LTA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
D961H sachet 20 mg
D961H HPMC capsule 20 mg
Arm Description
Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) and excipient granules filled into single-use aluminium sachets
Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) in HPMC capsule
Outcomes
Primary Outcome Measures
Description of whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg
To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5.
Secondary Outcome Measures
Description to compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH
To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5
Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.
To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.
Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.
To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01964131
Brief Title
BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects
Official Title
An Open Label, Randomised, Single Center, 2 Way Crossover Study to Assess Bioequivalence Between a Commercial HPMC Capsule of D961H 20 mg and a Pellets Based Sachet Formulation of D961H 20 mg by Pharmacodynamics (Intragastric pH) After Once-daily Repeated Oral Administration in Japanese Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>4.
To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH.
To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.
To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.
Detailed Description
The purpose of this study is; To investigate whether a pellets based sachet formulation of D961H 20 mg (D961H sachet 20 mg) is bioequivalent to a commercial HPMC capsule of D961H 20 mg (D961H HPMC capsule 20 mg) after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5.
To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5
To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.
To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer, Duodenal Ulcer, Anastomotic Ulcer, Reflux Esophagitis, Etc.
Keywords
Bioequivalence, pharmacodynamics, pharmacokinetics, safety, tolerability, D961H, Japanese
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D961H sachet 20 mg
Arm Type
Experimental
Arm Description
Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) and excipient granules filled into single-use aluminium sachets
Arm Title
D961H HPMC capsule 20 mg
Arm Type
Other
Arm Description
Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) in HPMC capsule
Intervention Type
Drug
Intervention Name(s)
D961H sachet 20 mg
Intervention Description
Each subject will be randomised evenly to one of "Treatment: A-->B (Sequence 1)" or "Treatment: B-->A (Sequence 2)".
Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg
Intervention Type
Drug
Intervention Name(s)
D961H HPMC capsule 20 mg
Intervention Description
Each subject will be randomised evenly to one of "Treatment: A-->B (Sequence 1)" or "Treatment: B-->A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg
Primary Outcome Measure Information:
Title
Description of whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg
Description
To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on Day 5.
Time Frame
27 days
Secondary Outcome Measure Information:
Title
Description to compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH
Description
To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median pH after dose on Day 5
Time Frame
27 days
Title
Description of the PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg.
Description
To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg after repeated oral doses by the assessment of AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss, and t1/2,ss of esomeprazole after dose on Day 5.
Time Frame
27 days
Title
Description of the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.
Description
To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg by the assessment of adverse events, clinical laboratory tests, blood pressure (BP), pulse rate and body temperature.
Time Frame
34 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated, written informed consent prior to any study specific procedures
Healthy Japanese male subjects between 20 and 45 years of age
Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
Body weight 50-85 kg
Negative for HIV antigen/antibody, Hepatitis B surface antigen, Hepatitis C antibody and syphilis
Clinically normal findings at the enrolment medical examination, as judged by the investigator(s)
Homo-EM according to the genotype of CYP2C19
Less than 30% of time with intragastric pH>4 during the baseline (pre-entry) 24-hr intragastric pH recording
Helicobacter pylori negative has been known by urea breath test as the volunteer panel data
Exclusion Criteria:
Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention
Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction
Past or present drug addiction or alcohol abuse
Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention
Moderate to heavy smoking or other sort of nicotine use (greater than 10 cigarettes per day or corresponding nicotine use)
Clinical significant condition which could modify the absorption of the investigational product, as judged by the investigator(s), eg, effect on the absorption of the investigational product by diarrhoea, or history of excision of parts of the stomach
Donation of blood in excess of 200 mL during the 1 month, in excess of 400 mL during the 3 months or in excess of 1200 mL during the 12 months before the first dosing of treatment period 1 (including blood component donation)
Need for concomitant medication in the study
Use of prescribed medication from the 2 weeks preceding the pre-entry visit to the randomisation, and over the counter (OTC) drugs (including herbs, vitamins and minerals) from one week preceding the pre-entry visit to the randomisation, unless approved by the investigator(s) and sponsor
Use of grapefruit and grapefruit juice, and health food containing St. John's wort consumption within 2 weeks prior to the first dosing of treatment period 1
Administration of any investigational product within 4 months preceding the pre-entry visit
Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site)
Clinical judgment by the investigator(s) that the subject should not participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megumi Inoue, MD, PhD
Organizational Affiliation
Hakata Clinic Medical Co. LTA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Hakata Clinic Medical Co. LTA
City
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
12. IPD Sharing Statement
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BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects
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