Bioequivalence of Two Pregabalin 300 mg capsules (Neurexal and Lyrica^®) in Healthy Human Volunteers

Abstract

The pharmacokinetics of 2 brands of pregabalin 300 mg capsules were compared in 23 healthy human volunteers after a single oral dose in a randomized cross-over study. The study protocol was prepared with relevance to the requirements set in the US FDA and the EMA guidances for conduction of bioequivalence studies. Reference (Lyrica^®, Pfizer, France) and test (Neurexal, Pharmaline, Lebanon) products were administered to fasted volunteers. Blood samples were collected up to 48 h and assayed for pregabalin using a validated LC-MS/MS method. The pharmacokinetic parameters AUC_0–t, AUC_0–∞, C_max, T_max, T_1/2 and elimination rate constant were determined from plasma concentration-time profile by non-compartmental analysis method using WinNonlin V5.2. The analysis of variance did not show any significant difference between the 2 formulations and 90% confidence intervals fell within the acceptable range for bioequivalence: 80–125%. It was concluded that the 2 brands exhibited comparable pharmacokinetic profiles and that Pharmaline’s Neurexal is bioequivalent to Lyrica^® of Pfizer, France.

Key words

pharmacokinetics - bioequivalence - pregabalin

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