NCT01570569

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Inje University · Academic / Other
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Omeprazole	Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
DRUG	Losartan	Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
DRUG	Dextromethorphan	Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
DRUG	Cocktail	Group A : Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days. Group B : Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.
DRUG	Midazolam	Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.
DRUG	Caffeine	Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2012-04-04
• Last updated: 2012-04-04