Pharmacokinetic profile and bioavailability of a new galenic formulation of ticlopidine.
J.P. Desager, Y. van Nieuwenhuyze, J Dricot, Yves Berger, C. Harvengt
Abstract
J.P. Desager, Y. van Nieuwenhuyze, J Dricot, Yves Berger, C. Harvengt
Abstract
The bioavailability of a new film-coated tablet of ticlopidine hydrochloride was compared in 12 healthy male subjects to that of the older sugar-coated tablet. Plasma levels of ticlopidine were measured by gas-liquid chromatography up to 120 h after a single 500 mg dose of each preparation. Drug intake was separated by a four-week interval. No statistically significant differences could be found between the pharmacokinetic parameters for these two preparations. Bioequivalence was confirmed when applying the test of Westlake to the area under the curves (calculated difference: 8.3%; upper limit: 20%). No unwanted effect was reported during the study.
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The bioavailability of a new film-coated tablet of ticlopidine hydrochloride was compared in 12 healthy male subjects to that of the older sugar-coated tablet. Plasma levels of ticlopidine were measured by gas-liquid chromatography up to 120 h after a single 500 mg dose of each preparation. Drug intake was separated by a four-week interval. No statistically significant differences could be found between the pharmacokinetic parameters for these two preparations. Bioequivalence was confirmed when applying the test of Westlake to the area under the curves (calculated difference: 8.3%; upper limit: 20%). No unwanted effect was reported during the study.
Key concepts: Bioequivalence, Bioavailability, Ticlopidine, Pharmacokinetics, Medicine, Pharmacology, Plasma concentration, Significant difference