NCT04075643

Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 in Healthy Volunteers

A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 in healthy volunteers.

Detailed description

To healthy subjects of fifty-two (52), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D935 Test drug: CKD-385 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	D935 Cap. 1 Cap., single oral administration under fasting condition
DRUG	Test drug	CKD-385 Tab. 1 Tab., single oral administration under fasting condition

Timeline

• Start date: 2019-09-19
• Primary completion: 2019-09-30
• Completion: 2019-10-30
• First posted: 2019-09-03
• Last updated: 2020-02-05

Locations

1 site across 1 country: South Korea