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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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D961H 40 mg gelatin capsule

2 way crossover

Group Type EXPERIMENTAL

D961H

Intervention Type DRUG

Oral gelatin capsule

D961H 40 mg HPMC capsule

2 way crossover

Group Type EXPERIMENTAL

D961H

Intervention Type DRUG

Oral HPMC capsule

Interventions

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D961H

Oral gelatin capsule

Intervention Type DRUG

D961H

Oral HPMC capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes