NCT02651753

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: 48 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

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.

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(Lipitor+Lipidil supra). Each treatment period was separated by a washout period of at least 7 days.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	Lipitor + Lipidil supra	Reference Drug: Lipitor + Lipidil supra
DRUG	CKD-337	Test Drug: CKD-337

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-03-01
• Completion: 2016-05-01
• First posted: 2016-01-11
• Last updated: 2016-07-07