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Study on relative bioavailability of two flunarizine hydrochloride capsules

Liu Hui‐chen

Open publisher page 1 citations

Abstract

OBJECTIVE To study the relative bioavailability of two flunarizine hydrochloride capsules in human.METHODS A single oral dose of 20 mg flunarizine hydrochloride capsules was given to 20 healthy male volunteers according to a randomized crossover design.The concentrations of flunarizine in plasma were determined by HPLC/MS assay.The pharmacokinetic parameters were processed with NDST program for variance analysis and two one-sided t test.RESULTS The main pharmacokinetic parameters of the test and the reference capsules were as follow:c max(53±15) ng·mL -1 and (52±15) ng·mL -1,t max (3.0±0.8) and (3.3±1.3) h,t 1/2 (8.1±1.2) and (8.2±2.0) h,AUC 0～24 (539±206) and (503±156) ng·h·mL -1 respectively.The relative bioavailability of the test capsules was (105.6±16.2)%.CONCLUSION The two capsules were bioequivalent.

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OBJECTIVE To study the relative bioavailability of two flunarizine hydrochloride capsules in human.METHODS A single oral dose of 20 mg flunarizine hydrochloride capsules was given to 20 healthy male volunteers according to a randomized crossover design.The concentrations of flunarizine in plasma were determined by HPLC/MS assay.The pharmacokinetic parameters were processed with NDST program for variance analysis and two one-sided t test.RESULTS The main pharmacokinetic parameters of the test and the reference capsules were as follow:c max(53±15) ng·mL -1 and (52±15) ng·mL -1,t max (3.0±0.8) and (3.3±1.3) h,t 1/2 (8.1±1.2) and (8.2±2.0) h,AUC 0～24 (539±206) and (503±156) ng·h·mL -1 respectively.The relative bioavailability of the test capsules was (105.6±16.2)%.CONCLUSION The two capsules were bioequivalent.

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Available abstract

OBJECTIVE To study the relative bioavailability of two flunarizine hydrochloride capsules in human.METHODS A single oral dose of 20 mg flunarizine hydrochloride capsules was given to 20 healthy male volunteers according to a randomized crossover design.The concentrations of flunarizine in plasma were determined by HPLC/MS assay.The pharmacokinetic parameters were processed with NDST program for variance analysis and two one-sided t test.RESULTS The main pharmacokinetic parameters of the test and the reference capsules were as follow:c max(53±15) ng·mL -1 and (52±15) ng·mL -1,t max (3.0±0.8) and (3.3±1.3) h,t 1/2 (8.1±1.2) and (8.2±2.0) h,AUC 0～24 (539±206) and (503±156) ng·h·mL -1 respectively.The relative bioavailability of the test capsules was (105.6±16.2)%.CONCLUSION The two capsules were bioequivalent.

Key concepts: Bioequivalence, Bioavailability, Pharmacokinetics, Flunarizine, Crossover study, Pharmacology, Chemistry, Chromatography

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