NCT01071720

The Effect of Food on the Pharmacokinetic Characteristics of CKD-501

Clinical Study to Assess the Effect of Food on the Pharmacokinetic Characteristics of CKD-501 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effect of food on the pharmacokinetic characteristics of CKD-501 in healthy subject. And, secondarily, pharmacokinetic characteristics of the main metabolites will be identified.

Detailed description

Healthy volunteers are administrated single-dose (CKD-501 1mg), two treatment(fed vs. fasting), two-period, two sequence crossover. Every time before and after each medication, PK parameters and safety of CKD-501 1mg is performed using a blood sample and conducting some tests respectively.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CKD-501 1mg	This study is randomized, balanced, single-dose, two treatment (fed versus fasting), two-period, two sequence crossover design to assess the effects of food on pharmacokinetics profile.

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-06-01
• Completion: 2010-08-01
• First posted: 2010-02-19
• Last updated: 2010-12-10