Journal of Bioequivalence & Bioavailability

Margarita Restrepo

Publications

• Research Article
  Bioequivalence Evaluation of Two Formulations of Lamotrigine Tablets in Healthy Volunteers
  Author(s): Adriana Ruiz, Fanny Cuesta, Sergio Parra, Blanca Montoya, Margarita Restrepo, Lina Peña, Gloria Holguín and Rosendo ArchboldAdriana Ruiz, Fanny Cuesta, Sergio Parra, Blanca Montoya, Margarita Restrepo, Lina Peña, Gloria Holguín and Rosendo Archbold
  
  Lamotrigine is a phenyltriazine used in the treatment of epilepsy and bipolar disorder type I. The purpose of this study was to compare the bioavailability in healthy Colombian volunteers of two brands of lamotrigine 100 mg tablets: a new generic formulation (test product) developed by Humax Pharmaceuticals S.A (Medellín, Col) and LAMICTAL® (reference product) from Glaxo Operations UK Ltd (Ware, UK). A single-dose, randomized, two-period, two-sequence crossover study, with six weeks washout period, was performed. Blood samples were obtained from 0 to 144 hours after dosing and plasma lamotrigine levels were determined by a validated high performance liquid chromatographic (HPLC) method. The 90% confidence intervals (CIs) for the ratios of the ln AUC0-∞ and ln Cmax means between the reference and test formulations were constructed under 80/125 rule for bioequivalence l.. View More»
  DOI: 10.4172/jbb.1000107

  Abstract PDF