Journal of Bioequivalence & Bioavailability

Regina Gómez-Palacio

Publications

• Research Article
  Relative Bioavailability of Chewable and Conventional Film-Coated Tablet Formulations of Sildenafil 100 mg in Healthy Volunteers Under Fasting Conditions
  Author(s): Fermin Valenzuela, Gabriela Davila, Yamanqui Ibañez, Luis Garcia, Penelope Crownover, Regina Gómez-Palacio, Juan Ovalle, Cesar Velasco and Bimal MalhotraFermin Valenzuela, Gabriela Davila, Yamanqui Ibañez, Luis Garcia, Penelope Crownover, Regina Gómez-Palacio, Juan Ovalle, Cesar Velasco and Bimal Malhotra
  
  Pharmacokinetics and bioavailability of a chewable tablet formulation of sildenafil citrate 100 mg developed using taste-masking technology and taken with or without water (chewed until full disintegration and then swallowed) versus the conventional film-coated sildenafil tablet (Viagra ® ) taken with water were evaluated in the fasted state in a randomized, open-label, single-dose, 3-period crossover study in 30 healthy men aged 18 to 40 years (mean ± SD, 24±4 y). Sildenafil plasma concentrations were determined using a validated high-performance liquid chromatography method with ultraviolet detection. Bioequivalence criteria were 90% classic and Westlake CIs within 80% to 125% for test/reference ratios; limit tests applied were Schuirmann unilateral double t test and the Anderson-Hauck test. For area under the curve (AUC), bioequivalence criteria were met for all t.. View More»
  DOI: 10.4172/jbb.1000087

  Abstract PDF