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An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics After Administration of CJ30001 and Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects
The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to healthy subjects.
Details
| Lead sponsor | HK inno.N Corporation |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | 2009-10 |
| Completion | 2009-11 |
Conditions
- Diabetes Mellitus
Interventions
- Period I : HKB0701 and SLM0807, Period II : CJ30001
- Period I : CJ30001, Period II : HKB0701 and SLM0807
Primary outcomes
- Geometric mean Cmax — up to 24hrs
- Geometric mean AUCt — up to 24hrs