NCT03601910

Clinical Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-380 10mg and D308 10mg

An Open-label, Randomized, Fasted, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-380 10mg and D308 10mg in Healthy Male Adults

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is an open-label, randomized, fasted, single-dose, 2-way crossover study to compare the pharmacokinetic characteristics and safety between CKD-380 10mg and D308 10mg in healthy male adults.

Detailed description

To healthy male subjects of thirty-four (34), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D308 10mg Tab. / Test drug: CKD-380 10mg Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions

• Type II Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	D308 10mg Tab.	D308 10mg Tab.1T single oral administration under fasting condition
DRUG	CKD-380 10mg Tab.	CKD-380(Dapagliflozin) 10mg Tab.1T single oral administration under fasting condition

Timeline

• Start date: 2018-07-16
• Primary completion: 2018-09-21
• Completion: 2018-11-09
• First posted: 2018-07-26
• Last updated: 2018-07-26

Locations

1 site across 1 country: South Korea