Pharmacokinetics and relative bioavailability of minocycline hydrochloride tablets
Hu Ben
Abstract
Hu Ben
Abstract
AIM: To study the phamacokinetics and relative bioavailability of minocycline hydrochloride tablets.METHODS: A single oral administration(200 mg) of minocycline hydrochloride tablets was given in 20 healthy male volunteers who were divided into 2 groups according to randomized crossover design.Minocycline hydrochloride concentrations in plasma were determined by high-performance liquid chromatography(HPLC).The pharmacokinetic parameters and relative bioavailability of tested tablets were calculated and compared with that of reference tablets.RESULTS: After a single oral administration(200 mg) of minocycline hydrochloride and reference tablets,the obtained pharmacokinetic parameters were as follows: T1/2 were(19.53±2.67) and(19.52±2.32) h;Tmax were(1.72±0.41) and(1.72±0.70)h;Cmax:(3.404±1.050) and(3.284±0.472) mg/L;AUC(0-60 h) were(62.50±11.77) and(56.93±7.33)(mg·h)/L,respectively.The relative bioavailability of tested tablets was 111.5%.No significant differences were found in the main pharmacokinetic parameters between the two kinds of tablets(P0.05).CONCLUSION: The two preparations present bioequivalence.
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AIM: To study the phamacokinetics and relative bioavailability of minocycline hydrochloride tablets.METHODS: A single oral administration(200 mg) of minocycline hydrochloride tablets was given in 20 healthy male volunteers who were divided into 2 groups according to randomized crossover design.Minocycline hydrochloride concentrations in plasma were determined by high-performance liquid chromatography(HPLC).The pharmacokinetic parameters and relative bioavailability of tested tablets were calculated and compared with that of reference tablets.RESULTS: After a single oral administration(200 mg) of minocycline hydrochloride and reference tablets,the obtained pharmacokinetic parameters were as follows: T1/2 were(19.53±2.67) and(19.52±2.32) h;Tmax were(1.72±0.41) and(1.72±0.70)h;Cmax:(3.404±1.050) and(3.284±0.472) mg/L;AUC(0-60 h) were(62.50±11.77) and(56.93±7.33)(mg·h)/L,respectively.The relative bioavailability of tested tablets was 111.5%.No significant differences were found in the main pharmacokinetic parameters between the two kinds of tablets(P0.05).CONCLUSION: The two preparations present bioequivalence.
Key concepts: Bioavailability, Bioequivalence, Pharmacokinetics, Cmax, Crossover study, Pharmacology, Hydrochloride, High-performance liquid chromatography