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Single-dose, Open, Randomized, Two-period, Crossover Comparative Bioavailability Study of Sanchi-Tongshu Capsule and Sanchi-Tongshu Capsule (Enteric Coated Pellets) in Chinese Healthy Adult Male Subjects
24 healthy male volunteers are to be assigned to take orally Sanchi-Tongshu Capsule (Enteric coated pellets) and Sanchi-Tongshu Capsule in fasting condition according to a randomized, crossover, self-control method, with ginsenoside Rg1, ginsenoside Re and notoginsenoside R1 as detection indicators. Establish the "blood drug concentration-time " curve, compare the bioequivalence of the main effective ingredients of the two preparations during the absorption process in human.
Details
| Lead sponsor | Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 23 |
| Start date | 2014-06 |
| Completion | 2014-12 |
Conditions
- Healthy
Interventions
- Sanchi-Tongshu Capsule (Enteric coated pellets)
- Sanchi-Tongshu Capsule
Primary outcomes
- Area under the plasma concentration-time curve from zero to 33 hours post dose(AUC0-33h) — Up to 33 hours post dose
- Area under the plasma concentration-time curve from zero to infinity post dose(AUC0-∞) — Up to 33 hours post dose
- Maximum observed concentration (Cmax ) — Up to 33 hours post dose
Countries
China