NCT04322032

Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-389

A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-389 in Healthy Volunteers Under Fasting Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 64 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-389 in healthy volunteers.

Detailed description

To healthy subjects of thirty-four (34), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug(D759 and D308), Test drug(CKD-389) Pharmacokinetic blood samples are collected up to 48 hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Reference drug	D759 Tab. 1 Tab. and D308 Tab. 1 Tab.(Total 2 Tab.), Single oral administration under fasting condition.
DRUG	Test drug	CKD-389 Tab. 1 Tab.(Total 1 Tab.), Single oral administration under fasting condition.

Timeline

• Start date: 2020-04-06
• Primary completion: 2020-05-12
• Completion: 2020-05-18
• First posted: 2020-03-26
• Last updated: 2020-03-26

Locations

1 site across 1 country: South Korea