NCT05552495

Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-386 in Healthy Volunteers Under Fasting Conditions

A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-386 With Co-administration of D013, D326, and D337 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (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 pharmacokinetic profiles and safety of CKD-386 in healthy volunteers under fasting conditions.

Detailed description

To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 14 days Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions

• Hypertension and Dyslipidemia

Interventions

Type	Name	Description
DRUG	CKD-386(4) F1	1 Tablet
DRUG	CKD-386(4) F2	1 Tablet
DRUG	D013, D326, D337	D013 1 Tablet, D326 1Tablet, D337 1 Tablet

Timeline

• Start date: 2022-09-23
• Primary completion: 2022-11-27
• Completion: 2022-12-12
• First posted: 2022-09-23
• Last updated: 2023-01-12

Locations

1 site across 1 country: South Korea