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An Open-label, Randomized, Single Dose, Crossover Phase I Clinical Trial to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab., 4T (400mg) in Healthy Male Volunteers
The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T (400mg) when administered a single-dose to healthy male volunteers.
Details
| Lead sponsor | Samyang Biopharmaceuticals Corporation |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | 2012-03 |
| Completion | 2012-04 |
Conditions
- Healthy
Interventions
- SYO-1126
- Glivec film coated tab 4T(400mg)
Primary outcomes
- Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg) — 0-72hr
- Pharmacokinetics of the Cmax SYO-1126 anf Glivec Film coated tab 4T(400mg) — 0-72hr
Countries
South Korea