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2002•The Chinese Journal of Clinical PharmacologyRequires access

Pharmacokinetics and Relative Bioavailablity of Gatifloxacin Capsule in Human Volunteers

Qiu Fu

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Abstract

OBJECTIVE: To study pharmacokinetics and bioavailablity of Gatifloxacin capsule in 20 healthy volunteers. METHODS:According to the crossover design, each volunteer was orally given Gatifloxacin capsule and tablet. The plasma concentrations were determined by HPLC. Pharmacokinetic parameters were obtained using excel ,and were calculated on the basis of noncompartment model.RESULTS: After a single oral dose(0.4g), t1/2 was 6.49±0.84 h and 6.80±0.96 h, Cmax was4.27±0.65 mg·L-1 and 4.16±0.84mg·L-1 at 1.5±0.6 h and 1.6±0.7h and AUC 0-36 was33.33±4.23mg·h·L-1 and 30.99±3.15 mg·h·L-1 for tested formulation and referenced formulation, respectively. Relative bioavailability of gatifloxacin capsule was(105.84+9.63)%. CONLUTION: The result shows that two formulations are of bioequivalence .

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What this paper is about

OBJECTIVE: To study pharmacokinetics and bioavailablity of Gatifloxacin capsule in 20 healthy volunteers. METHODS:According to the crossover design, each volunteer was orally given Gatifloxacin capsule and tablet. The plasma concentrations were determined by HPLC. Pharmacokinetic parameters were obtained using excel ,and were calculated on the basis of noncompartment model.RESULTS: After a single oral dose(0.4g), t1/2 was 6.49±0.84 h and 6.80±0.96 h, Cmax was4.27±0.65 mg·L-1 and 4.16±0.84mg·L-1 at 1.5±0.6 h and 1.6±0.7h and AUC 0-36 was33.33±4.23mg·h·L-1 and 30.99±3.15 mg·h·L-1 for tested formulation and referenced formulation, respectively. Relative bioavailability of gatifloxacin capsule was(105.84+9.63)%. CONLUTION: The result shows that two formulations are of bioequivalence .

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Available abstract

OBJECTIVE: To study pharmacokinetics and bioavailablity of Gatifloxacin capsule in 20 healthy volunteers. METHODS:According to the crossover design, each volunteer was orally given Gatifloxacin capsule and tablet. The plasma concentrations were determined by HPLC. Pharmacokinetic parameters were obtained using excel ,and were calculated on the basis of noncompartment model.RESULTS: After a single oral dose(0.4g), t1/2 was 6.49±0.84 h and 6.80±0.96 h, Cmax was4.27±0.65 mg·L-1 and 4.16±0.84mg·L-1 at 1.5±0.6 h and 1.6±0.7h and AUC 0-36 was33.33±4.23mg·h·L-1 and 30.99±3.15 mg·h·L-1 for tested formulation and referenced formulation, respectively. Relative bioavailability of gatifloxacin capsule was(105.84+9.63)%. CONLUTION: The result shows that two formulations are of bioequivalence .

Key concepts: Gatifloxacin, Bioequivalence, Capsule, Pharmacokinetics, Cmax, Bioavailability, Volunteer, Pharmacology

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