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Report for Clinical Trial NCT00676117

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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).

NCT00676117 Healthy

2 Interventions

Name: Esomeprazole (D961H)

Description: 20mg

Type: Drug

1

Name: Loxoprofen

Description: 60mg tablet

Type: Drug

2


Primary Outcomes

Measure: 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: 5-7 days after the last dose of study medication is given

Secondary Outcomes

Measure: 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: 5-7 days after the last dose of study medication is given

Purpose: Treatment

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 D961H

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. --- D961H ---

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). --- D961H ---

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). --- D961H --- --- D961H ---

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). --- D961H --- --- D961H --- --- D961H ---

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.. null. --- D961H ---

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.. null. --- D961H --- --- D961H ---

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. --- D961H ---



HPO Nodes