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

Cardiovascular Diseases Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04083846
Study type Interventional
Source Chong Kun Dang Pharmaceutical
Contact
Status Completed
Phase Phase 1
Start date September 6, 2019
Completion date October 25, 2019
View Details
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