Study to Assess the Pharmacodynamics/Pharmacokinetics After Repeated Dosing of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Pharmacodynamics Study

Treatments

Drug: D961H

Drug: Omeprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01159145

D961HC00009

Details and patient eligibility

About

The purpose of this study is to assess the pharmacodynamics (intragastric pH) after repeated oral administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects who are classified by the genotype of CYP2C19 by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on day 5.

Enrollment

42 estimated patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy Japanese male subjects between 20 and 45 years of age
Genotype of CYP2C19 has been known as the volunteer panel data
H. pylori negative has been known by urea breath test as the volunteer panel data.

Exclusion criteria

Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention
Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction
Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention (eg, anesthetics used at the intragastric pH measurement)