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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Loxoprofen; Drug: Esomeprazole (D961H)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00676117

D961HC00007

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Esomeprazole (D961H)

2

Active Comparator group

Treatment:

Drug: Loxoprofen