NCT03346187

A Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337

A Randomized, Open-label, Single Oral Dose, 2-way Crossover Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetic characteristics of CKD-337 in healthy male volunteers

Detailed description

This study is a randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetics of CKD-337 in healthy male volunteers. Subjects will receive either a single oral dose of the test formulation(CKD-337) or a oral dose of the reference formulation(Atorvastatin Calcium Trihydrate+Fenofibrate). Each treatment period was separated by a washout period of at least 7 days.

Conditions

• Dyslipidemias

Interventions

Type	Name	Description
DRUG	Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate)	Lipitor(Atorvastatin Calcium Trihydrate 20mg/tablet) + Lipidil supra(Fenofibrate 160mg/tablet)
DRUG	Test drug(CKD-337)	CKD-337(Atorvastatin calcium trihydrate 20mg+choline fenofibrate 178.8mg/capsule)

Timeline

• Start date: 2017-05-19
• Primary completion: 2017-05-31
• Completion: 2017-06-13
• First posted: 2017-11-17
• Last updated: 2017-12-19

Locations

1 site across 1 country: South Korea