NCT02854748

Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin

A Randomized, Open-label, Multiple Dosing, Crossover Study to Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin in Healthy Male Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, open-label, multiple dosing, crossover study to evaluate the drug-drugs interaction between Lobeglitazone and Empagliflozin in healthy male volunteers

Detailed description

To healthy male subjects of 30, following treatments are administered dosing in each 3 period(Lobeglitazone or Empagliflozin or Lobe.+Empa.) and wash-out period is a minimum of 7 days. Test Drug 1: Lobeglitazone 0.5mg 1T Test Drug 2: Empagliflozin 25mg 1T Pharmacokinetic blood samples are collected up to 24hrs. Safety, pharmacokinetic and the drug-drugs interaction are assessed.

Conditions

• Diabetes Mellitus, Type II

Interventions

Type	Name	Description
DRUG	Empagliflozin 25mg	Empagliflozin 25 mg QD for 5 days
DRUG	Lobeglitazone 0.5mg	Lobeglitazone 0.5mg QD for 5 days
DRUG	Empagliflozin 25mg/Lobeglitazone 0.5mg	Empagliflozin 25 mg + Lobeglitazone 0.5mg QD for 5 days

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-08-03
• Last updated: 2016-08-09

Locations

1 site across 1 country: South Korea