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Completed

NCT Number: NCT00676117

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

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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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Osaka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole (D961H)

Drug

20mg

Other names: Nexium

Loxoprofen

Drug

60mg tablet

Other names: Loxonin

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 12, 2008
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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