NCT04611932

Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-333 Low Dose in Healthy Volunteers

A Randomized, Open-label, Single Dose, 3-period Partial Replicated Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-333 Low Dose in Healthy Volunteers Under Fasting Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 54 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, open-label, single dose, 3-period partial replicated crossover study to evaluate the pharmacokinetic profiles and safety of CKD-333 low dose in healthy volunteers under fasting conditions.

Detailed description

To healthy subjects of fifty-one (51), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. Reference drug: 1) Cantabell Tab. 8/5mg 2) Lipitor Tab. 10mg / Test drug: CKD-333 8/5/10mg Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	CKD-330 Tab. and D090 Tab.	1T
DRUG	CKD-333 Tab.	1T

Timeline

• Start date: 2020-11-11
• Primary completion: 2021-03-10
• Completion: 2021-04-27
• First posted: 2020-11-02
• Last updated: 2020-11-02

Locations

1 site across 1 country: South Korea