Journal of Bioequivalence & Bioavailability

Ultra Laboratorios, S.A. de C.V. Av. Roberto Michel #2920, Col. Álamo Industrial, C.P. 44490, Guadalajara, Jalisco, Mexico

Publications

• Research Article   
  Single-Dose, Randomized, Open-Label, Two-Way, Crossover Bioequivalence Studies of two formulations of 500-mg Delayed-Release Valproate semisodium Tablets in Healthy Mexican Population Under Fasted and Fed Conditions
  Author(s): Alberto Martínez-Muñoz*, Juan Luis Gutiérrez-Velázquez, Porfirio de la Cruz-Cruz, Luis Eligio Chablé-Cen, Fabiola Esmeralda Penilla-Flores, Juan Ernesto Dávila-Romero, Héctor Manuel González-Martín, Araceli Guadalupe Medina-Nolasco, Sandra Lara-Figueroa, Ricardo Zamora-Ramírez and José Luis Rubio-Santiago
  
  Therapeutic adherence has a key role in the clinical improvement of a disease; the adherence pattern of Immediate- Release formulation of Valproic Acid is relatively lower due to several gastrointestinal adverse events. Therefore, these studies evaluated the bioequivalence of a new 500 mg Delayed-Release Valproate Acid Tablets in Mexican population. The test formulation (Vupelsat®) was manufactured by Ultra Laboratorios S.A. de C.V. (Jalisco, Mexico) with batch number: DE-LPP-20016-A and expiration date March 2022 the reference formulation (Epival®) was manufactured by Abbott Laboratories de México, S.A. de C.V. (Mexico) with batch number: 08222MC and expiration date August 2021. The studies designs were: Single-center, single-dose, open-label, two-way, crossover with a 7-day wash-out period before the next dosing. Study A was .. View more»
  

  DOI: 10.35248/0975-0851.22.S8.003

  Abstract HTML PDF