Open-label, Randomized, Single-dose, 2-way Crossover Study to Investigate Safety and Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.

NCT01443221 Phase 1 COMPLETED

To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose combination of mitiglinide/metformin, compared with free combination of mitiglinide and metformin in healthy male subjects.

Details

Lead sponsor	JW Pharmaceutical
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2010-12
Completion	2011-01

Conditions

• Healthy

Interventions

• mitiglinide and metformin
• mitiglinide and metformin

Primary outcomes

• Compare the pharmacokinetic profiles(Cmax, AUClast) of fixed-dose combination versus free dose combination in healthy volunteers — Up to 36 hours postdose for each period

Countries

South Korea