NCT01761513

YH4808 Postprandial PK/PD Study in Healthy Subjects

A Randomized,Open Label,Active-controlled, Multiple Dosing and Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of YH4808 After Postprandial Oral Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	YH4808	Group1 1. adminitration of YH4808 dose1, bid for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of YH4808 dose2, qd for 2weeks
DRUG	YH4808	Group2 1. adminitration of YH4808 dose2, qd for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of YH4808 dose1, bid for 2weeks
DRUG	YH4808	Group3 1. adminitration of YH4808 dose2, bid for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of Nexium tab 40mg, bid for 2weeks
DRUG	YH4808	Group 4 1. adminitration of Nexium tab 40mg, bid for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of YH4808 dose2, bid for 2weeks

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-02-01
• Completion: 2014-02-01
• First posted: 2013-01-04
• Last updated: 2014-04-15

Locations

1 site across 1 country: South Korea