NCT04260438

Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects

An Open-label, Randomized, Fed, Single Dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is an open-label, randomized, fed, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-393 in healthy subjects

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: 1) CKD-501 0.5mg 2) D759 3) D150 Test drug: 1) CKD-393 0.5/100/1000mg formulation Ⅰ Tab. 2) CKD-393 0.5/100/1000mg formulation Ⅱ Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T	single oral administration under fed condition
DRUG	CKD-393 0.5/100/1000mg formulation 1 Tab. 1T	single oral administration under fed condition
DRUG	CKD-393 0.5/100/1000mg formulation 2 Tab. 1T	single oral administration under fed condition

Timeline

• Start date: 2020-04-08
• Primary completion: 2020-06-15
• Completion: 2020-06-24
• First posted: 2020-02-07
• Last updated: 2021-04-30

Locations

1 site across 1 country: South Korea