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Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males

NCT ID: NCT00676117

Last Updated: 2009-03-12

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetic profile of Esomeprazole (D961H) during repeated oral administration with and without co-administration of loxoprofen and the pharmacokinetic profile of loxoprofen during repeated oral administration with and without co-administration of Esomeprazole (D961H).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Esomeprazole (D961H)

Intervention Type DRUG

20mg

2

Group Type ACTIVE_COMPARATOR

Loxoprofen

Intervention Type DRUG

60mg tablet

Interventions

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Esomeprazole (D961H)

20mg

Intervention Type DRUG

Loxoprofen

60mg tablet

Intervention Type DRUG

Other Intervention Names

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Nexium Loxonin

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese male
* Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
* Body weight 50-80 kg

Exclusion Criteria

* Past or present NSAIDs induced asthma, hepatic dysfunction, peptic ulcer or blood disorders
* 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
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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Naotsugu Oyama, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca

Michio Yagi

Role: PRINCIPAL_INVESTIGATOR

Osaka Pharmacology Clinical Research Hospital

Locations

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Research Site

Osaka, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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D961HC00007

Identifier Type: -

Identifier Source: org_study_id

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