NCT07304726

Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.25/12.5/1000mg in Healthy Volunteers

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 2 Tablets and Co-administration of CKD-501, D745 and D150 for Healthy Adult Volunteers in Fasting State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-383 in healthy volunteers

Detailed description

To 30 healthy subjects, following treatments, are administered dosing in each period and wash-out period is 7 days. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	CKD-383 0.25/12.5/1000mg	QD, PO
DRUG	CKD-501, D745, D150	QD, PO

Timeline

• Start date: 2025-10-30
• Primary completion: 2025-11-09
• Completion: 2025-11-23
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: South Korea