Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets
Status:
Completed
Trial end date:
2019-06-28
Target enrollment:
Participant gender:
Summary
The sponsor, Pfizer has developed a formulation of tramadol hydrochloride/ paracetamol 37.5
mg/ 325 mg (test drug) as a generic alternative to the reference listed product Ultracet®. In
order to meet the requirements for registration as a generic drug, this study is being
conducted to demonstrate the bioequivalence between the formulation of tramadol
hydrochloride/ paracetamol 37.5 mg/ 325 mg provided by Pfizer and the reference drug tramadol
hydrochloride/ paracetamol 37.5 mg/ 325 mg, available in the pharmaceutical market in Brazil
(Ultracet®, Janssen Cilag Farmacêutica Ltda).