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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacodynamics Study

Intervention: D961H (Drug); Omeprazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Masataka Date, MD PhD, Study Director, Affiliation: AstraZeneca KK
Ippei Ikushima, MD, PhD, Principal Investigator, Affiliation: AstraZeneca KK

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 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Primary outcome: To assess the pharmacodynamics (intragastric pH) after repeated administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects by the assessment of percentage of time with intragastric pH>4.

Secondary outcome:

To assess the pharmacodynamics (intragastric pH) after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median intragastric pH.

To assess the pharmacokinetics after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of plasma concentrations and AUCt, AUCt, Css,max, tmax, and t1/2 for D961H and omeprazole after dose on day 5.

To assess the safety and the tolerability after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of adverse events, laboratory variables, pulse rate, blood pressure, body temperature and 12-lead ECG

Eligibility

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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)

Locations and Contacts

Research Site, Tokyo, Japan
Additional Information

Starting date: July 2010
Last updated: September 19, 2010

Page last updated: August 23, 2015

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