Status:
COMPLETED
Study to Assess the Pharmacodynamics/Pharmacokinetics After Repeated Dosing of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Pharmacodynamics Study
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
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 classifie...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01159145
Start Date
July 1 2010
End Date
September 1 2010
Last Update
September 21 2010
Active Locations (1)
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1
Research Site
Tokyo, Tokyo, Japan