Clinical Research Center, Medical Life Science Institute, Department of Medical Sciences, Ministry of Public Health, Nonthaburi 11000, Thailand
Research Article
Assessment of Bioequivalence of Two Tramadol Hydrochloride 100 mg Extended-Release Tablet Formulations in Healthy Thai Volunteer
Author(s): 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 quan.. View more»