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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00676117
First received: May 8, 2008
Last updated: March 11, 2009
Last verified: March 2009
  Purpose

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).


Condition Intervention Phase
Healthy
Drug: Esomeprazole (D961H)
Drug: Loxoprofen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Esomeprazole (D961H)
20mg
Other Name: Nexium
Active Comparator: 2 Drug: Loxoprofen
60mg tablet
Other Name: Loxonin

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676117

Locations
Japan
Research Site
Osaka-city, Osaka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Naotsugu Oyama, MD, PhD AstraZeneca
Principal Investigator: Michio Yagi Osaka Pharmacology Clinical Research Hospital
  More Information

No publications provided

Responsible Party: Tore Lind - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00676117     History of Changes
Other Study ID Numbers: D961HC00007
Study First Received: May 8, 2008
Last Updated: March 11, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
male
Japan
Japanese
Healthy volunteers

Additional relevant MeSH terms:
Esomeprazole
Loxoprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Proton Pump Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014