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

Inje University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Omeprazole; Drug: Cocktail; Drug: Losartan; Drug: Caffeine; Drug: Dextromethorphan; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01570569

10-152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Subject who has abnormal laboratory test results

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 5 patient groups

Omeprazole

Active Comparator group

Treatment:

Drug: Cocktail

Drug: Omeprazole

Losartan

Active Comparator group

Treatment:

Drug: Losartan

Drug: Cocktail

Dextromethorphan

Active Comparator group

Treatment:

Drug: Dextromethorphan

Drug: Cocktail

Caffeine

Active Comparator group

Treatment:

Drug: Caffeine

Drug: Cocktail

Midazolam

Active Comparator group

Treatment:

Drug: Midazolam

Drug: Cocktail