Development of Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Omeprazole; Drug: Dextromethorphan; Drug: Losartan; Drug: Cocktail; Drug: Caffeine; Drug: Midazolam

• Registration Number: NCT01570569
• Lead Sponsor: Inje University

Brief Summary

The investigators objectives were developing mini dose five-drug cocktail regimen to evaluate potential drug-drug interactions associated with use of a cocktail of caffeine, losartan, omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A activities.

Detailed Description

The investigators objectives were developing minidose five-drug cocktail regimen to evaluate potential drug-drug interactions associated with use of a cocktail of caffeine, losartan, omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A activities.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-12-06
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-01
• Last Update Submitted: 2012-04-01
• Study First Posted: 2012-04-04
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

• Healthy male subject whose CYP2C9, CYP2C19, CYP2D6 genotype was determined

Exclusion Criteria

• Subject who has abnormal laboratory test results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omeprazole	Omeprazole	-
Omeprazole	Cocktail	-
Losartan	Cocktail	-
Dextromethorphan	Dextromethorphan	-
Dextromethorphan	Cocktail	-
Caffeine	Cocktail	-
Midazolam	Cocktail	-
Losartan	Losartan	-
Caffeine	Caffeine	-
Midazolam	Midazolam	-

Primary Outcome Measures

Name	Time	Method
Cmax, AUC	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose