Journal of Bioequivalence & Bioavailability

Rajeswara Rao P

Publications

• Research Article
  Intra Subject Variability of Progesterone 200 mg Soft Capsules in Indian Healthy Adult Postmenopausal Female Subjects under Fasting Conditions
  Author(s): Rajeswara Rao P and Someswara Rao KRajeswara Rao P and Someswara Rao K
  
  The aim of this study was to evaluate the intra subject variability of progesterone 200 mg soft capsules of Test product with Prometrium® (Progesterone USP) capsules 200 mg (Reference) marketed by Solvay Pharmaceuticals Inc., Marietta, GA in healthy adult, human, post-menopausal female volunteers. This study was an open label, randomized, balanced, single-dose, two sequence two period, crossover oral bioequivalence study was conducted in 12 healthy adult, human, post-menopausal female volunteers under fasting conditions. Subjects received progesterone 200 mg of either test or reference formulation with a washout period of 10 days. After study drug administration, serial blood samples were collected over a period of 36 hours post dose. The plasma concentrations of progesterone were determined by a validated method using LC/MS/MS. Pharmacokinetic parameters Cmax, Tmax, AUC0-t, AUC0-.. View More»
  DOI: 10.4172/jbb.10000194

  Abstract PDF