Bioequivalence study comparing D961H sachet and D961H capsule in Japanese healthy male subjects
Study identifier:D961TC00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
Medical condition
Bioequivalence study
Phase
Phase 1
Healthy volunteers
Yes
Study drug
D961H Sachet 20 mg, D961H HPMC capsule 20 mg
Sex
Male
Actual Enrollment
71
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 May 2012
Primary Completion Date: 01 Jun 2012
Study Completion Date: 01 Jun 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: D961H Sachet 20 mg 2 way crossover | Drug: D961H Sachet 20 mg Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days. Other Name: esomeprazole sachet |
| Experimental: D961HHPMC Capsule 20 mg 2 way crossover | Drug: D961H HPMC capsule 20 mg Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days. Other Name: esomeprazole Other Name: capsule 20 mg |
Contacts
Investigators
Principal Investigator
Masataka Date
AstraZeneca R&D Japan
