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Drug Res (Stuttg) 2014; 64(7): 358-362
DOI: 10.1055/s-0033-1361127
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

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

A. Al-Ghazawi
1   Triumpharma LLC; Clinical Evaluation Centre, Amman, Jordan
,
N. Idkaidek
1   Triumpharma LLC; Clinical Evaluation Centre, Amman, Jordan
2   College of Pharmacy, University of Petra, Amman, Jordan
,
E. Daccache
3   Research & Development Department, Pharmaline, Jdeidet-El-Metn, Lebanon
,
J.-C. Sarraf
3   Research & Development Department, Pharmaline, Jdeidet-El-Metn, Lebanon
,
S. Kyriacos
3   Research & Development Department, Pharmaline, Jdeidet-El-Metn, Lebanon
› Author Affiliations
Further Information

Publication History

received 23 May 2013

accepted 18 October 2013

Publication Date:
04 December 2013 (online)

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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 AUC0–t, AUC0–∞, Cmax, Tmax, T1/2 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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