NCT04019743

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers

A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, open-label, fasted, single dose, crossover study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.

Detailed description

To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. Reference drug: 1) CKD-330 16/10mg Tab. 2) D086 Tab. Test drug: 1) CKD-333 16/10/40mg formulation 1 Tab. 2) CKD-333 16/10/40mg formulation 2 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions

• Hypertension
• Dyslipidemias

Interventions

Type	Name	Description
DRUG	CKD-330 16/10mg Tab. 1T and D086 Tab. 1T	single oral administration under fasting condition
DRUG	CKD-333 16/10/40mg formulation 1 Tab. 1T	single oral administration under fasting condition
DRUG	CKD-333 16/10/40mg formulation 2 Tab. 1T	single oral administration under fasting condition

Timeline

• Start date: 2019-07-28
• Primary completion: 2019-08-30
• Completion: 2019-09-04
• First posted: 2019-07-15
• Last updated: 2020-01-30

Locations

1 site across 1 country: South Korea