NCT04083872

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

To 16 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D744 Test drug: CKD-385 64 mg formulation I 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 fasting condition
DRUG	Test drug	CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fasting condition

Timeline

• Start date: 2019-09-06
• Primary completion: 2019-10-21
• Completion: 2019-11-01
• First posted: 2019-09-10
• Last updated: 2020-02-05

Locations

1 site across 1 country: South Korea