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2003•Zhongguo yaoke daxue xuebaoRequires access

Determination of Zaleplon in Human Plasma by HPLC-MS

Ma Ren

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Abstract

AIM:To study the pharmacokinetics and relative bioavailability of zaleplon capsules. METHOD:zaleplon capsules(10 mg) and tablets(10 mg) were given to 20 healthy male volunteers in an open randomized crossover study . HPLC-MS was established for the determination of zaleplon in human plasma.The relative bioavailability and bioequivalence of zaleplon capsules were determined by comparing with zaleplon tablets. RESULT: c _ max of zaleplon in blood for capsules and tablets are (46.76±10.73) and (43.85±12.29) ng/ml at 1.18±0.41 and 1.16±0.31 h respectively. T _ 1/2 are 0.92±0.16 and 1.08±0.24 h respectively. The relative bioavailability of capsules comparing with tablets was (98.2±12.9)%. CONCLUTION:The two formulations were bioequivalent.

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AIM:To study the pharmacokinetics and relative bioavailability of zaleplon capsules. METHOD:zaleplon capsules(10 mg) and tablets(10 mg) were given to 20 healthy male volunteers in an open randomized crossover study . HPLC-MS was established for the determination of zaleplon in human plasma.The relative bioavailability and bioequivalence of zaleplon capsules were determined by comparing with zaleplon tablets. RESULT: c _ max of zaleplon in blood for capsules and tablets are (46.76±10.73) and (43.85±12.29) ng/ml at 1.18±0.41 and 1.16±0.31 h respectively. T _ 1/2 are 0.92±0.16 and 1.08±0.24 h respectively. The relative bioavailability of capsules comparing with tablets was (98.2±12.9)%. CONCLUTION:The two formulations were bioequivalent.

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Available abstract

AIM:To study the pharmacokinetics and relative bioavailability of zaleplon capsules. METHOD:zaleplon capsules(10 mg) and tablets(10 mg) were given to 20 healthy male volunteers in an open randomized crossover study . HPLC-MS was established for the determination of zaleplon in human plasma.The relative bioavailability and bioequivalence of zaleplon capsules were determined by comparing with zaleplon tablets. RESULT: c _ max of zaleplon in blood for capsules and tablets are (46.76±10.73) and (43.85±12.29) ng/ml at 1.18±0.41 and 1.16±0.31 h respectively. T _ 1/2 are 0.92±0.16 and 1.08±0.24 h respectively. The relative bioavailability of capsules comparing with tablets was (98.2±12.9)%. CONCLUTION:The two formulations were bioequivalent.

Key concepts: Bioequivalence, Bioavailability, Pharmacokinetics, Chemistry, Chromatography, Plasma concentration, Crossover study, Pharmacology

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