NCT04676893

Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 45 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 subjects of fifty-six (56), 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: 2021-02-26
• Primary completion: 2021-05-11
• Completion: 2021-05-18
• First posted: 2020-12-21
• Last updated: 2020-12-21

Locations

1 site across 1 country: South Korea