Bioequivalence study comparing D961H sachet and D961H capsule in Japanese healthy male subjects

Study identifier:D961TC00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Medical condition

Bioequivalence study

Phase

Phase 1

Healthy volunteers

Yes

Study drug

D961H Sachet 20 mg, D961H HPMC capsule 20 mg

Sex

Male

Actual Enrollment

71

Study type

Interventional

Age

20 Years - 45 Years

Date

Study Start Date: 01 May 2012
Primary Completion Date: 01 Jun 2012
Study Completion Date: 01 Jun 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria