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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

NCT ID: NCT01159145

Last Updated: 2010-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pharmacodynamics Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

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D961H 10 mg capsule

2 way crossover

Group Type EXPERIMENTAL

D961H

Intervention Type DRUG

Oral, capsule

Omeprazole 10 mg tablet

2 way crossover

Group Type EXPERIMENTAL

Omeprazole

Intervention Type DRUG

Oral, tablet

Interventions

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D961H

Oral, capsule

Intervention Type DRUG

Omeprazole

Oral, tablet

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Masataka Date, MD PhD

Role: STUDY_DIRECTOR

AstraZeneca KK

Ippei Ikushima, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca KK

Locations

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Research Site

Tokyo, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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D961HC00009

Identifier Type: -

Identifier Source: org_study_id