Summary： To study the bioequivalence of a kind of progesterone sustained release suppository, a randomized cross over study was conducted in 12 rabbits. A single rectal dose of 2.75 mg/kg progesterone sustained relea...Summary： To study the bioequivalence of a kind of progesterone sustained release suppository, a randomized cross over study was conducted in 12 rabbits. A single rectal dose of 2.75 mg/kg progesterone sustained released suppository （tested formulation, T） and progesterone suppository （reference formulation, R） was administered; a muhiple dose of 2.75 mg/kg was given up to seven times with an interval of 8 h. Concentrations in serum were determined by a competitive enzyme immunoassay. The main parameters of T were： for single and multiple doses, C was 48.8±11.8 ng/mL and 43.5±9.4 ng/mL. Tmax was 0.5±0.3 h and 0. 4±0.3 h, AUC〈（0-21h） was 362. 4±143 ng·h·mL^-1 and 310.6±70. 3 ng·h·mL^-1 , respectively. The relative bioavailability of T to R were （104.2±13.4） % and （111.4±19. 1） %, respectively. Statistical analysis showed that the two formulations were bioequivalent and T had sustained released feature.展开更多
To study the bioequivalence of Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets, a randomized cross over study was conducted in 18 healthy volunteers. A single oral dose of 1000 mg Clav ulanate Pot...To study the bioequivalence of Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets, a randomized cross over study was conducted in 18 healthy volunteers. A single oral dose of 1000 mg Clav ulanate Potassium and Amoxicillin (1:7) dispersible tablets (Tested formulation, T) or Augmentin syrup (Reference formulation, R). Concentrations in plasma were determined with high performance liquid chromatography. The main paramaters of T were: for Clavulanate Potassium and Amoxicillin, C max : 2.46±1.11 μg/m l and 18.81±7.26 μg/ml, T max : 1.12±0.23h and 1.30±0.34h, AUC (0 - 6 h) : 5.18±2.24 μg·h/ml and 45.09±14.53 μg·h/ml, t 1/2 : 1.43±0.44 h and 1.09±0.22 h., respectively. The relative bioavailability of T to R were 9 6.5±19.2 % and 98.4±26.1 % , respectively. Statistical analysis showed that th e two formulations were bioequivalent.展开更多
文摘Summary： To study the bioequivalence of a kind of progesterone sustained release suppository, a randomized cross over study was conducted in 12 rabbits. A single rectal dose of 2.75 mg/kg progesterone sustained released suppository （tested formulation, T） and progesterone suppository （reference formulation, R） was administered; a muhiple dose of 2.75 mg/kg was given up to seven times with an interval of 8 h. Concentrations in serum were determined by a competitive enzyme immunoassay. The main parameters of T were： for single and multiple doses, C was 48.8±11.8 ng/mL and 43.5±9.4 ng/mL. Tmax was 0.5±0.3 h and 0. 4±0.3 h, AUC〈（0-21h） was 362. 4±143 ng·h·mL^-1 and 310.6±70. 3 ng·h·mL^-1 , respectively. The relative bioavailability of T to R were （104.2±13.4） % and （111.4±19. 1） %, respectively. Statistical analysis showed that the two formulations were bioequivalent and T had sustained released feature.
文摘To study the bioequivalence of Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets, a randomized cross over study was conducted in 18 healthy volunteers. A single oral dose of 1000 mg Clav ulanate Potassium and Amoxicillin (1:7) dispersible tablets (Tested formulation, T) or Augmentin syrup (Reference formulation, R). Concentrations in plasma were determined with high performance liquid chromatography. The main paramaters of T were: for Clavulanate Potassium and Amoxicillin, C max : 2.46±1.11 μg/m l and 18.81±7.26 μg/ml, T max : 1.12±0.23h and 1.30±0.34h, AUC (0 - 6 h) : 5.18±2.24 μg·h/ml and 45.09±14.53 μg·h/ml, t 1/2 : 1.43±0.44 h and 1.09±0.22 h., respectively. The relative bioavailability of T to R were 9 6.5±19.2 % and 98.4±26.1 % , respectively. Statistical analysis showed that th e two formulations were bioequivalent.
