NCT02827890

CKD-396 Drug-drug Interaction Study(B) (CKD-396 DDI(B) P1)

A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Effect of Lobeglitazoneon Pharmacokinetics of Sitagliptin in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate a pharmacokinetic drug interaction between sitagliptin and lobeglitazone in healthy male volunteers.

Detailed description

To healthy male subjects of twenty(20), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days.

Conditions

• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
DRUG	Januvia Tab. 100mg	Januvia Tab. 100mg\*1T/day for 5days, QD, PO
DRUG	Januvia Tab. 100mg + Duvie Tab. 0.5mg	Januvia Tab.100mg + Duvie Tab. 0.5mg\*1T/day for 5 dyas, QD, PO

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-04-01
• Completion: 2016-05-01
• First posted: 2016-07-11
• Last updated: 2017-08-09

Locations

1 site across 1 country: South Korea