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Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects

NCT ID: NCT01595425

Last Updated: 2012-12-12

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-06-30

Brief Summary

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This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.

Detailed Description

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A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Conditions

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Bioequivalence Study

Keywords

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Bioequivalence, pharmacokinetics, safety, esomeprazole, Japanese, healthy subject, homo-EM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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D961H Sachet 20 mg

2 way crossover

Group Type EXPERIMENTAL

D961H Sachet 20 mg

Intervention Type DRUG

Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days.

D961HHPMC Capsule 20 mg

2 way crossover

Group Type EXPERIMENTAL

D961H HPMC capsule 20 mg

Intervention Type DRUG

Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days.

Interventions

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D961H Sachet 20 mg

Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days.

Intervention Type DRUG

D961H HPMC capsule 20 mg

Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days.

Intervention Type DRUG

Other Intervention Names

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esomeprazole sachet esomeprazole capsule 20 mg

Eligibility Criteria

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Inclusion Criteria

1. Provision of signed and dated, written informed consent prior to any study specific procedures
2. Japanese healthy male subjects aged 20 to 45 years of age
3. Body Mass Index 19-27 kg/m2 and body weight 50-85 kg
4. Clinically normal findings
5. Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19

Exclusion Criteria

1. Significant clinical illness
2. Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
3. Clinical significant condition which could modify the absorption of the investigational product
4. Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention
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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Responsibility Role SPONSOR

Principal Investigators

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Masataka Date

Role: STUDY_DIRECTOR

AstraZeneca R&D Japan

Masanari Shiramoto

Role: PRINCIPAL_INVESTIGATOR

Hakata Clinic

Locations

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Research Unit

Fukuoka, Fukuoka, Japan

Site Status

Countries

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Japan

Other Identifiers

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D961TC00001

Identifier Type: -

Identifier Source: org_study_id