NCT04083846

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)

A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fed Conditions

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

Summary

This study is a randomized, open-label, fed, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions.

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 7 days. Reference drug: D744, Test drug 1: CKD-385 64 mg formulation I, Test drug 2: CKD-385 64 mg formulation II. Pharmacokinetic blood samples are collected up to 48 hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Reference drug	D744 Cap. 1 Cap., single oral administration under fed condition
DRUG	Test drug 1	CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fed condition
DRUG	Test drug 2	CKD-385 64 mg formulation II Tab. 1 Tab., single oral administration under fed condition

Timeline

• Start date: 2019-09-06
• Primary completion: 2019-10-21
• Completion: 2019-10-25
• First posted: 2019-09-10
• Last updated: 2020-02-05

Locations

1 site across 1 country: South Korea