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2007•Chinese Journal of Clinical PharmacyRequires access

Bioequivalence of azithromycin tablets in healthy volunteers

Jiang Xin-guo

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Abstract

AIM To evaluate the bioequivalence of azithromycin tablets in healthy male volunteers. METHODS Twenty healthy male volunteers were given a single oral dose of 500 mg azithromycin tablets in a randomized crossover study. Plasma drug levels were determined by HPLC-MS method. RESULTS The tmax,ρmax,t1/2 AUC0→144h and AUC0→∞of azithromycin for tested and reference tablets were (1. 9±0. 4), (2. 1±0. 5) h; (382. 67±94. 96), (390.00±57.80)μg·L-1;(48.40±7.92),(47.08±7.66)h;(3525.31±949.10),(3708.13±1085.98)μg·h·L-1;(3 894.86±1 138.13), (4 054.76±1 238. 47)μg·h·L-1, respectively. The relative bioavailability of azithromycin tablets was (97.4±16.5)%. CONCLUSION There is no statistical difference in pharmacokinetic parameters between reference and tested formulations and they are proved to be bioequivalent.

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AIM To evaluate the bioequivalence of azithromycin tablets in healthy male volunteers. METHODS Twenty healthy male volunteers were given a single oral dose of 500 mg azithromycin tablets in a randomized crossover study. Plasma drug levels were determined by HPLC-MS method. RESULTS The tmax,ρmax,t1/2 AUC0→144h and AUC0→∞of azithromycin for tested and reference tablets were (1. 9±0. 4), (2. 1±0. 5) h; (382. 67±94. 96), (390.00±57.80)μg·L-1;(48.40±7.92),(47.08±7.66)h;(3525.31±949.10),(3708.13±1085.98)μg·h·L-1;(3 894.86±1 138.13), (4 054.76±1 238. 47)μg·h·L-1, respectively. The relative bioavailability of azithromycin tablets was (97.4±16.5)%. CONCLUSION There is no statistical difference in pharmacokinetic parameters between reference and tested formulations and they are proved to be bioequivalent.

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Available abstract

AIM To evaluate the bioequivalence of azithromycin tablets in healthy male volunteers. METHODS Twenty healthy male volunteers were given a single oral dose of 500 mg azithromycin tablets in a randomized crossover study. Plasma drug levels were determined by HPLC-MS method. RESULTS The tmax,ρmax,t1/2 AUC0→144h and AUC0→∞of azithromycin for tested and reference tablets were (1. 9±0. 4), (2. 1±0. 5) h; (382. 67±94. 96), (390.00±57.80)μg·L-1;(48.40±7.92),(47.08±7.66)h;(3525.31±949.10),(3708.13±1085.98)μg·h·L-1;(3 894.86±1 138.13), (4 054.76±1 238. 47)μg·h·L-1, respectively. The relative bioavailability of azithromycin tablets was (97.4±16.5)%. CONCLUSION There is no statistical difference in pharmacokinetic parameters between reference and tested formulations and they are proved to be bioequivalent.

Key concepts: Bioequivalence, Azithromycin, Bioavailability, Pharmacokinetics, Crossover study, Pharmacology, Medicine, Oral dose

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