Study Comparing Gelatine Capsule 40 mg D961H and HPMC capsule in Japanese healthy males
Study identifier:D961HC00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Open label, Randomized, Single center, 2-way Crossover Bioequivalence Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule 40 mg D961H After Repeated Oral Administration in Japanese Healthy Male Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
D961H
Sex
Male
Actual Enrollment
48
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Jun 2009
Primary Completion Date: -
Study Completion Date: 01 Aug 2009
Study design
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: D961H 40 mg gelatin capsule 2 way crossover | Drug: D961H Oral gelatin capsule |
| Experimental: D961H 40 mg HPMC capsule 2 way crossover | Drug: D961H Oral HPMC capsule |
Contacts
Investigators
Principal Investigator
Takenobu Masaoka
AstraZeneca
