A Bioequivalence Study of Sanchi-Tongshu Capsule (Enteric Coated Pellets)
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Pharmaceutical Factory of Chengdu HuaSun Group Inc., Ltd.
Collaborators:
Sichuan University West China Second University Hospital