Journal of Bioequivalence & Bioavailability

Hemlata Nigam

Publications

• Research Article
  Evaluation of Inter-Occasion Variability on Trospium Pharmacokinetics in Healthy Human Subjects using Non-Compartment Methods
  Author(s): Sundara Moorthi Nainar Murugesan, Ravisekhar Kasibhatta, Prabakaran Desomayandhan, Saji Vijayan, Vijay Tate, Hemlata Nigam, Ashish Saxena, Praveen Kumar Vittala and Sikandar Ali KhanSundara Moorthi Nainar Murugesan, Ravisekhar Kasibhatta, Prabakaran Desomayandhan, Saji Vijayan, Vijay Tate, Hemlata Nigam, Ashish Saxena, Praveen Kumar Vittala and Sikandar Ali Khan
  
  Objective: The main objective of this study was to assess the impact of inter-occasion variability (IOV) on Trospium plasma concentration level from typical crossover pharmacokinetic study using non-compartment model analysis. Methods: An open, randomized, fasting, single-dose, two way crossover reference replicate study was performed with 36 healthy, non-smoking, male subjects. Plasma concentration of Trospium was estimated. The influence of inter-occasion on Trospium pharmacokinetics was evaluated using non-compartment model analysis. Results: Results from the non-compartment analyses showed that inter-occasion variability as measured by coefficient of variation was found more than 30% for pharmacokinetic parameters Cmax, AUClast and Vd/F. In addition, IOV for Cmax was higher when compared with any other pharmacokinetic parameters. Conclusion: Overall, considerable variability assoc.. View More»
  DOI: 10.4172/jbb.1000205

  Abstract PDF