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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Unit

Fukuoka-shi, Fukuoka, Japan

Arms	Assigned Interventions
Experimental: D961H Sachet 20 mg 2 way crossover	Drug: D961H Sachet 20 mg Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days. Other Name: esomeprazole sachet
Experimental: D961HHPMC Capsule 20 mg 2 way crossover	Drug: D961H HPMC capsule 20 mg Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days. Other Name: esomeprazole Other Name: capsule 20 mg

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=711&filename=CSR-D961TC00001.pdf
Download
CSR-D961TC00001.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Masataka Date

AstraZeneca R&D Japan