Study to assess the Pharmacodynamics/Pharmacokinetics after repeated dosing of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects

Study identifier:D961HC00009

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomised, single blind, two-way cross-over, single-centre study to assess the pharmacodynamics (intragastric pH) and pharmacokinetics after repeated oral administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects

Medical condition

Pharmacodynamics study

Phase

Phase 1

Healthy volunteers

Yes

Study drug

D961H, Omeprazole

Sex

Male

Actual Enrollment

42

Study type

Interventional

Age

20 Years - 45 Years

Date

Study Start Date: 01 Jul 2010
Primary Completion Date: 01 Sept 2010
Study Completion Date: 01 Sept 2010

Study design

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Other

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria