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

March 11, 2009 updated by: AstraZeneca

A Single-Centre, Open, Randomised, Three-Way Cross-Over Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Healthy Male Subjects

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Osaka-city, Osaka, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Esomeprazole (D961H)
20mg
Other Names:
  • Nexium
Active Comparator: 2
Drug: Loxoprofen
60mg tablet
Other Names:
  • Loxonin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pharmacokinetic profile of D961H during repeated administration with and without co-administration of loxoprofen and pharmacokinetic profile of loxoprofen during repeated administration with and without co-administration of D961H, assessing plasma conc.
Time Frame: 5-7 days after the last dose of study medication is given
5-7 days after the last dose of study medication is given

Secondary Outcome Measures

Outcome Measure
Time Frame
The safety of D961H with and without coadministration of loxoprofen by assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, urinalysis and haemoccult test), ECG, blood pressure, pulse rate and body temperature
Time Frame: 5-7 days after the last dose of study medication is given
5-7 days after the last dose of study medication is given

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Naotsugu Oyama, MD, PhD, AstraZeneca
  • Principal Investigator: Michio Yagi, Osaka Pharmacology Clinical Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

May 8, 2008

First Submitted That Met QC Criteria

May 9, 2008

First Posted (Estimate)

May 12, 2008

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 11, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D961HC00007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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