Bioequivalence Study of Atorvastatin Tablets in Healthy Pakistani Volunteers

Étude de bioequivalence des comprimés d’atorvastatine chez des volontaires sains pakistanais

¹ College of Pharmacy, Shifa Tameer-e-Millat University, Islamabad, Pakistan
² College of Pharmacy, Government College University, Faisalabad, Pakistan
³ Department of Pharmacy, University of the Punjab, Lahore, Pakistan
⁴ Department of Pharmacy, Comsats Institute of Information Technology, Abbottabad, Pakistan

Correspondence and offprints: Wajahat Mahmood, Department of Pharmacy, Comsats Institute of Information Technology, Abbottabad, Pakistan. E-mail: wmahmood@ciit.net.pk

Received: 19 September 2013
Accepted: 24 October 2014

Abstract

A two way, randomized cross-over bioequivalence study was conducted to analyse the rate and extent of absorption of atorvastatin after a single dose of 80 mg atorvastatin as atorvastatin calcium tablets. The study was carried out using healthy male volunteers (N = 24). A high performance liquid chromatography method was employed to determine the level of drug in human plasma. It was concluded that the test and the reference drug exhibited comparable values of pharmacokinetic parameters. It was also concluded that since there was no significant difference between the rate and extent of absorption of the drug from the test and the reference formulations: these two formulations could thus be declared bioequivalent.

Résumé

Une étude de bioéquivalence randomisée en cross-over a été menée pour évaluer l’absorption de l’atorvastatine 80 mg en comparaison de l’un de ses génériques. L’étude a été réalisée sur 24 volontaires sains de sexe masculin. Les dosages plasmatiques ont été réalisés par chromatographie en phase liquide haute performance. Dans ces conditions, les paramètres pharmacocinétiques mesurés étaient similaires. En particulier, il n’y avait pas de différence d’absorption entre la molécule originale et son générique l’ensemble permettant de conclure à la bioéquivalence des deux produits.