NCT04952506

Clinical Study to Compare the Pharmacokinetics and Safety of D113 With CKD-349 in Healthy Volunteers

A Randomized, Open-label, Single-dosing, 3-treatment, 6-sequence, 3-period, Crossover-design Pilot Clinical Trial to Compare the Safety and Pharmacokinetics of D113 With CKD-349 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, open-label, single dosing, 3-treatment, 6-sequence, 3-period, crossover-design study to compare the pharmacokinetics and safety of D113 with CKD-349 in healthy volunteers.

Detailed description

To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: Entresto 200mg / Test drug: 1) CKD-349 F1 Tab. 2) CKD-349 F2 Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions

• Chronic Renal Failure

Interventions

Type	Name	Description
DRUG	CKD-349 F1 Tab.	1T Single does
DRUG	CKD-349 F2 Tab.	1T Single does
DRUG	D113 Tab.	1T Single does

Timeline

• Start date: 2021-07-19
• Primary completion: 2021-07-29
• Completion: 2021-08-20
• First posted: 2021-07-07
• Last updated: 2024-01-24

Locations

1 site across 1 country: South Korea