Journal of Bioequivalence & Bioavailability

Uma Kuruganti

Publications

• Research Article
  Pharmacokinetics of a Novel Orodispersible Tablet of Amlodipine in Healthy Subjects
  Author(s): Vincent Mascoli, Uma Kuruganti, Akula Thukaram Bapuji, Rong Wang and Bharat Damle Vincent Mascoli, Uma Kuruganti, Akula Thukaram Bapuji, Rong Wang and Bharat Damle
  
  Purpose: An orally disintegrating tablet (ODT) of amlodipine has been developed for the benefit of patients who have difficulty swallowing solid dosage forms. Methods: Two pivotal bioequivalence studies of amlodipine ODT given with and without water, versus either amlodipine tablets or capsules, were conducted in 36 subjects each. Both studies were randomized, open-label, crossover, single-dose (10 mg) studies in healthy subjects ages 18 to 55 years. Plasma samples were collected for 168 hours post dose and pharmacokinetics were determined by non-compartmental analyses. Results: Amlodipine ODT with or without water was bioequivalent to amlodipine tablets as the ratio (90% CI) of Cmax, AUC∞, and AUClast were contained within 80–125%. Amlodipine ODT with or without water was also bioequivalent to amlodipine capsules as the ratio (90% CI) of Cmax, AUC∞, and AUClast were.. View More»
  DOI: 10.4172/jbb.1000138

  Abstract PDF