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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
23
Take 0.7g (2 Capsules) of test preparation orally.
Take 0.4g (2 Capsules) of reference preparation orally.
West China Second University Hospital
Chengdu, Sichuan, China
Area under the plasma concentration-time curve from zero to 33 hours post dose(AUC0-33h)
Time frame: Up to 33 hours post dose
Area under the plasma concentration-time curve from zero to infinity post dose(AUC0-∞)
Time frame: Up to 33 hours post dose
Maximum observed concentration (Cmax )
Time frame: Up to 33 hours post dose
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