2005Zhōnghuá yàoxué zázhìRequires access

Pharmacokinetics and bioavailability of sustained release melatonin tablets in healthy dogs by HPLC-MS

HE Zhong-gui

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Abstract

OBJECTIVE To compare data of pharmacokinetics and bioavailability between sustained release melatonin tablets and commercial tablets.METHODS A single oral dose of 6 mg test or reference preparations was given to 6 healthy dogs in a randomized crossover study. The serum concentrations of melatonin were determined by HPLC-MS method. RESULTS The pharmacokinetic parameters of two kinds of tablets were as Mows:tmax(2.08±0.20),(1.13±0.59) h;ρmax(4.66±6.87),(6.54±6.16)μg·L-1;AUC(13.21±17.21),(11.48± 5.37)μg·h·L-1.CONCLUSION The relative bioavailability of sustained release tablets is(87.79±72.68)% compared with the commercial tablets.The two formulations are bioequivalent.

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OBJECTIVE To compare data of pharmacokinetics and bioavailability between sustained release melatonin tablets and commercial tablets.METHODS A single oral dose of 6 mg test or reference preparations was given to 6 healthy dogs in a randomized crossover study. The serum concentrations of melatonin were determined by HPLC-MS method. RESULTS The pharmacokinetic parameters of two kinds of tablets were as Mows:tmax(2.08±0.20),(1.13±0.59) h;ρmax(4.66±6.87),(6.54±6.16)μg·L-1;AUC(13.21±17.21),(11.48± 5.37)μg·h·L-1.CONCLUSION The relative bioavailability of sustained release tablets is(87.79±72.68)% compared with the commercial tablets.The two formulations are bioequivalent.

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Available abstract

OBJECTIVE To compare data of pharmacokinetics and bioavailability between sustained release melatonin tablets and commercial tablets.METHODS A single oral dose of 6 mg test or reference preparations was given to 6 healthy dogs in a randomized crossover study. The serum concentrations of melatonin were determined by HPLC-MS method. RESULTS The pharmacokinetic parameters of two kinds of tablets were as Mows:tmax(2.08±0.20),(1.13±0.59) h;ρmax(4.66±6.87),(6.54±6.16)μg·L-1;AUC(13.21±17.21),(11.48± 5.37)μg·h·L-1.CONCLUSION The relative bioavailability of sustained release tablets is(87.79±72.68)% compared with the commercial tablets.The two formulations are bioequivalent.

Key concepts: Bioequivalence, Bioavailability, Pharmacokinetics, Crossover study, Pharmacology, Melatonin, High-performance liquid chromatography, Chemistry

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