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Comparison of Pharmacokinetics and Bioavailability of Roxithromycin Between Domestic Capsule and Tablet in Healthy Subjects

HU Jinghong

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Abstract

OBJECTIVE:To compare the pharmacokinetics and bioavailability of roxithromycin (Rox) between capsule and tablet.METHODS:Eight healthy volunteers were given two preparations with a single oral dose of 300 mg in a randomized crossover study.Serum concentrations of Rox were measured by bioassay.RESULTS:The concentration-time curves of capsule and tablet fitted to a two-compartment open model.Cmax reached at (10 14±1 66) and (10 02±1 84)μg/ml,Tmax at (1 44±0 32) and (1 31±0 26)h,and AUC were (79 87±16 22) and (73 86±13 46)h/(μg·ml),respectively.CONCLUSIONS:The pharmacokinetic parameters showed no significant difference between two products.Both formulations are in bioequivalence.The relative bioavailability of capsule to tablet is (109±15)%.

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OBJECTIVE:To compare the pharmacokinetics and bioavailability of roxithromycin (Rox) between capsule and tablet.METHODS:Eight healthy volunteers were given two preparations with a single oral dose of 300 mg in a randomized crossover study.Serum concentrations of Rox were measured by bioassay.RESULTS:The concentration-time curves of capsule and tablet fitted to a two-compartment open model.Cmax reached at (10 14±1 66) and (10 02±1 84)μg/ml,Tmax at (1 44±0 32) and (1 31±0 26)h,and AUC were (79 87±16 22) and (73 86±13 46)h/(μg·ml),respectively.CONCLUSIONS:The pharmacokinetic parameters showed no significant difference between two products.Both formulations are in bioequivalence.The relative bioavailability of capsule to tablet is (109±15)%.

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Available abstract

OBJECTIVE:To compare the pharmacokinetics and bioavailability of roxithromycin (Rox) between capsule and tablet.METHODS:Eight healthy volunteers were given two preparations with a single oral dose of 300 mg in a randomized crossover study.Serum concentrations of Rox were measured by bioassay.RESULTS:The concentration-time curves of capsule and tablet fitted to a two-compartment open model.Cmax reached at (10 14±1 66) and (10 02±1 84)μg/ml,Tmax at (1 44±0 32) and (1 31±0 26)h,and AUC were (79 87±16 22) and (73 86±13 46)h/(μg·ml),respectively.CONCLUSIONS:The pharmacokinetic parameters showed no significant difference between two products.Both formulations are in bioequivalence.The relative bioavailability of capsule to tablet is (109±15)%.

Key concepts: Bioavailability, Bioequivalence, Roxithromycin, Pharmacokinetics, Capsule, Cmax, Crossover study, Pharmacology

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Comparison of Pharmacokinetics and Bioavailability of Roxithromycin Between Domestic Capsule and Tablet in Healthy Subjects — Research Paper | ScholarLens