NCT05189288

Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388(2) in Healthy Subjects

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects

Detailed description

To healthy 60 subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. Reference drug: D418 Tab. / Test drug: CKD-388 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	D418 Tab.	1T
DRUG	CKD-388 Tab.	1T

Timeline

• Start date: 2022-01-14
• Primary completion: 2022-03-12
• Completion: 2022-04-15
• First posted: 2022-01-12
• Last updated: 2022-09-28

Locations

1 site across 1 country: South Korea