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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: D961H

Study type: Interventional

Funder types: Industry

Identifiers

NCT00930215

D961HC00008

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

48 participants in 2 patient groups

D961H 40 mg gelatin capsule

Experimental group

Description:

2 way crossover

Treatment:

Drug: D961H

Drug: D961H

D961H 40 mg HPMC capsule

Experimental group

Description:

2 way crossover

Treatment:

Drug: D961H

Drug: D961H