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RELATIVE BIOAVAILABILITY OF GEMFIBROZIL CAPSULE

Xi Chen

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Abstract

After oral administration of two kinds of gemfibrozil capsules in 8 healthy volunteers,the drug was extracted from the serum samples, then methylated and determined by gas chromatographyOne compartment model was fitted to the concentration-time profiles. Pharmacokinetic parameters forproduct A (Wuxi 7th pharmaceutical factory) werc k_α=2.97±2.84 h~(-1), k=0.761±0.215 h~(-1), t_(max)=1.42±0.83 h, C_(max)=21.68±6.5 mg/l, t_0=0.65±0.52 h, V/F=0.122±0.040 l and AUC=61.4±14.0mg·h~(-1) respectively; for the product B (PARKE-DAVIS Company) were ka=3.26±2.94 h~(-1), k=0.712±0.266 h~(-1), t_(max)=1.26±0.54 h, C_(max)=18.56±7.46 mg/l, t_0=0.33±0.43 h. V/F=0.153±0.045 l.AUC=53.74±10.57 mg·h~(-1). Relative bioavailability of product A was 1.14 compared with product B.4 of volunteers were subjected to administrated the drug 3 times daily (τ=6 h, X_0=300 mg), C_(max)and C_(min)were determined, which were very close to the simulated values.

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What this paper is about

After oral administration of two kinds of gemfibrozil capsules in 8 healthy volunteers,the drug was extracted from the serum samples, then methylated and determined by gas chromatographyOne compartment model was fitted to the concentration-time profiles. Pharmacokinetic parameters forproduct A (Wuxi 7th pharmaceutical factory) werc k_α=2.97±2.84 h~(-1), k=0.761±0.215 h~(-1), t_(max)=1.42±0.83 h, C_(max)=21.68±6.5 mg/l, t_0=0.65±0.52 h, V/F=0.122±0.040 l and AUC=61.4±14.0mg·h~(-1) respectively; for the product B (PARKE-DAVIS Company) were ka=3.26±2.94 h~(-1), k=0.712±0.266 h~(-1), t_(max)=1.26±0.54 h, C_(max)=18.56±7.46 mg/l, t_0=0.33±0.43 h. V/F=0.153±0.045 l.AUC=53.74±10.57 mg·h~(-1). Relative bioavailability of product A was 1.14 compared with product B.4 of volunteers were subjected to administrated the drug 3 times daily (τ=6 h, X_0=300 mg), C_(max)and C_(min)were determined, which were very close to the simulated values.

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Available abstract

After oral administration of two kinds of gemfibrozil capsules in 8 healthy volunteers,the drug was extracted from the serum samples, then methylated and determined by gas chromatographyOne compartment model was fitted to the concentration-time profiles. Pharmacokinetic parameters forproduct A (Wuxi 7th pharmaceutical factory) werc k_α=2.97±2.84 h~(-1), k=0.761±0.215 h~(-1), t_(max)=1.42±0.83 h, C_(max)=21.68±6.5 mg/l, t_0=0.65±0.52 h, V/F=0.122±0.040 l and AUC=61.4±14.0mg·h~(-1) respectively; for the product B (PARKE-DAVIS Company) were ka=3.26±2.94 h~(-1), k=0.712±0.266 h~(-1), t_(max)=1.26±0.54 h, C_(max)=18.56±7.46 mg/l, t_0=0.33±0.43 h. V/F=0.153±0.045 l.AUC=53.74±10.57 mg·h~(-1). Relative bioavailability of product A was 1.14 compared with product B.4 of volunteers were subjected to administrated the drug 3 times daily (τ=6 h, X_0=300 mg), C_(max)and C_(min)were determined, which were very close to the simulated values.

Key concepts: Bioavailability, Gemfibrozil, Pharmacokinetics, Capsule, Chemistry, Chromatography, Pharmacology, Medicine

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