Overview

Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males

Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
0
Participant gender:
Male
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
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AstraZeneca
Criteria
Inclusion Criteria:

- Healthy Japanese

- Classified as homo-EM

- Negative for HIV, Hepatitis B, Hepatitis C and syphilis

Exclusion Criteria:

- Significant clinical illness from 2 weeks preceding the pre-entry visit to the
randomization

- Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease