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A Randomized, Open-label, Single Dose, 2-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers
This study is A randomized, open-label, single dose, 2-way crossover study to investigate the effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male volunteers.
Details
| Lead sponsor | Chong Kun Dang Pharmaceutical |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 26 |
| Start date | 2015-10 |
| Completion | 2015-11 |
Conditions
- Diabetes Mellitus, Type II
Interventions
- CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T
- CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T
Primary outcomes
- AUClast of Lobeglitazone — 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
- AUClast of Metformin — 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
- Cmax of Lobeglitazone — 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
- Cmax of Metformin — 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Countries
South Korea