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Journal of Bioequivalence & Bioavailability

Abstract

Assessment of Bioequivalence of Two Tramadol Hydrochloride 100 mg Extended-Release Tablet Formulations in Healthy Thai Volunteer

Vipada Khaowroongrueng*, Wiwat Supasena, Polsak Teerawonganan, Ekawan Yoosakul, Lalinthip Saeaue, Busarat Karachot, Isariya Techatanawat, Archawin Rojanawiwat and Praphassorn Surawattanawan

Tramadol hydrochloride 100 mg extended-release tablets is available as the registered trademark, Tramal® retard in Thailand to reduce a dosing frequency for the treatment of moderate to severe pain. The Government Pharmaceutical Organization had developed the generic tramadol hydrochloride 100 mg extended-release tablets (Tramadol retard GPO®) to serve as an alternative product which is more accessible and affordable without compromising quality. Two separate single-dose bioequivalence studies under fasting and fed conditions and one multiple-dose bioequivalence study under fasting conditions were conducted in healthy Thai volunteers using a comparative randomized, two-way crossover, open-label design to demonstrate the equivalence in bio pharmaceutics quality between two tramadol formulations. Tramadol plasma concentrations were quantified using a validated liquid chromatography-mass spectrometry method. The 90% confidence intervals for the geometric least squares mean ratios of log-transformed AUC0-tlast, AUC0-∞ and Cmax for the single-dose studies and log-transformed AUC 0-τ,ss, Cτ,ss and C max,ssfor the multiple-dose study were within 80.00%-125.00% of bioequivalence criteria. The analysis of variance did not show significant effect of the formulation on the primary pharmacokinetic parameters. Wilcoxon signed-rank test also showed no significant difference in median tmax between two formulations in any studies. Bioequivalence between the test and reference products was concluded based on insignificant difference in terms of rate and extent of absorption.

Published Date: 2022-06-09; Received Date: 2022-05-05