title: 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 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.
authors.affiliation: Triumpharma LLC; Clinical Evaluation Centre, Amman, Jordan.
authors.forename: A
authors.initials: A
authors.lastname: Al-Ghazawi
authors.affiliation: Triumpharma LLC; Clinical Evaluation Centre, Amman, Jordan.
authors.forename: N
authors.initials: N
authors.lastname: Idkaidek
authors.affiliation: Research & Development Department, Pharmaline, Jdeidet-El-Metn, Lebanon.
authors.forename: E
authors.initials: E
authors.lastname: Daccache
authors.affiliation: Research & Development Department, Pharmaline, Jdeidet-El-Metn, Lebanon.
authors.forename: J-C
authors.initials: JC
authors.lastname: Sarraf
authors.affiliation: Research & Development Department, Pharmaline, Jdeidet-El-Metn, Lebanon.
authors.forename: S
authors.initials: S
authors.lastname: Kyriacos
mesh_terms: D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D002214:Capsules / Q000008:administration & dosage* / Q000737:chemistry; D002853:Chromatography, Liquid / Q000379:methods; D018592:Cross-Over Studies; D064368:Healthy Volunteers; D006801:Humans; D000069583:Pregabalin; D053719:Tandem Mass Spectrometry / Q000379:methods; D013810:Therapeutic Equivalency; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry
chemical_list: D002214:Capsules; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid