NCT01520012

Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects

Clinical Trial to Investigate the Influence of Food on Safety/Tolerability and Pharmacokinetics of YH4808 After Oral Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	YH4808 100 mg	Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days
DRUG	YH4808 100 mg	Period1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days
DRUG	YH4808 300 mg	Period1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal)
DRUG	YH4808 300 mg	Period1: YH4808 300 mg fed condition(high fat meal) Period2: YH4808 300 mg fasting condition Period3: YH4808 300 mg fed condition(standard meal)
DRUG	YH4808 300 mg	Period1: YH4808 300 mg fed condition(standard meal) Period2: YH4808 300 mg fed condition(high fat meal) Period3: YH4808 300 mg fasting condition

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2012-01-27
• Last updated: 2012-07-24

Locations

1 site across 1 country: South Korea