Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males
NCT00930215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2009-09-10
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
Conditions
- Healthy
Interventions
- DRUG
-
D961H
Oral gelatin capsule
- DRUG
-
D961H
Oral HPMC capsule
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Takenobu Masaoka · AstraZeneca
-
Masataka Date · AstraZeneca KK
-
Shunji Matsuki · Kyushu Clinical Pharmacology Research Clinic
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-06-30
- Completion
- 2009-08-31
Countries
- Japan
Study Locations
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