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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00676117

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 I

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Loxoprofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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

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
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Esomeprazole (D961H) 20mg
2: Active Comparator	Drug: Loxoprofen 60mg tablet

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

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

Contacts

Contact: AstraZeneca KK Corporate Communications

+81 6 6453 8011

Locations

Japan, Osaka
Research Site	Recruiting
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

Responsible Party:	AstraZeneca ( Tore Lind - Medical Science Director )
Study ID Numbers:	D961HC00007
Study First Received:	May 8, 2008
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00676117
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

male
Japan
Japanese
Healthy volunteers

Study placed in the following topic categories:

Loxoprofen
Omeprazole
Healthy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Anti-Ulcer Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009