NCT03210649

Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519

A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519 After Oral Administration in Healthy Adult Volunteers : Part I- Single Dosing / Part II- Multiple Dosing

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519

Detailed description

A randomized, double-blind, placebo-controlled, phase I clinical trial to investigate the safety/tolerability and pharmacokinetics/pharmacodynamics of CKD-519 after oral administration in healthy adult volunteers Part I- single dosing / Part II- multiple dosing

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	CKD-519	Part 1 : CKD-519(100mg x 4 Tablets) for D1 Part 2 : CKD-519(100mg x 4 Tablets) for D1\~D14
DRUG	Placebo	Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1\~D14

Timeline

• Start date: 2017-03-07
• Primary completion: 2017-04-24
• Completion: 2017-04-24
• First posted: 2017-07-07
• Last updated: 2017-07-07

Locations

1 site across 1 country: South Korea