Status:
COMPLETED
Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5
Eligibility Criteria
Inclusion
- Healthy Japanese
- Classified as homo-EM
- Negative for HIV, Hepatitis B, Hepatitis C and syphilis
Exclusion
- Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00930215
Start Date
June 1 2009
End Date
August 1 2009
Last Update
September 10 2009
Active Locations (1)
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1
Research Site
Fukuoka, Japan