An Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of HCP1201 Tablet in Healthy Volunteers

NCT01901757 Phase 1 COMPLETED

To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in fed versus fasted condition

Details

Lead sponsor	Hanmi Pharmaceutical Company Limited
Phase	Phase 1
Status	COMPLETED
Enrolment	12
Start date	2013-06
Completion	2013-07

Conditions

• Diabetes Mellitus

Interventions

• HCP1201, Fasted followed by fed
• HCP1201, Fed followed by fasted

Primary outcomes

• Metformin, rosuvastatin Cmax, AUClast — pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

Countries

South Korea