NCT06399055

Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-387 in Healthy Volunteers Under Fasting Conditions

A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-387 in Healthy Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-387 in healthy volunteers under fasting conditions.

Detailed description

To 36 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions

• Endocrine, Nutritional and Metabolic Diseases

Interventions

Type	Name	Description
DRUG	CKD-387	1 Tablet
DRUG	D484	1 Tablet

Timeline

• Start date: 2022-09-16
• Primary completion: 2022-09-26
• Completion: 2022-10-09
• First posted: 2024-05-03
• Last updated: 2024-05-03

Locations

1 site across 1 country: South Korea