Journal of Bioequivalence & Bioavailability

Naidu R

Publications

• Review Article
  Comparison of Pharmacokinetic and Pharmacodynamic Effects of Two Hydrofluoroalkane Formulations of Salmeterol
  Author(s): Morde N, Rebello J, Brashier B, Garg M, Naidu R, Birhade A, Iyer K and Jadhav RMorde N, Rebello J, Brashier B, Garg M, Naidu R, Birhade A, Iyer K and Jadhav R
  
  Introduction: To compare the Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of two Hydrofluoroalkane (HFA) formulations of salmeterol xinafoate (Test HFA formulation, Cipla Ltd., India; Reference HFA formulation, Allen and Hanburys, UK) administered using pressurized metered dose inhalers. Methods: Three separate randomized, crossover, PK studies and one PD study comparing the efficacy and safety of the two HFA formulations of salmeterol xinafoate (25 μg per actuation) in healthy subjects were conducted. The PK assessments of the two formulations were done without charcoal blockade, with charcoal blockade, and with a Volumatic spacer device using a single dose. A PD study was also conducted to evaluate the systemic exposure of the two formulations using three different doses (50 μg, 150 μg and 300 μg). Results: In the PK study without charcoal, the 90% CI fo.. View More»
  DOI: 10.4172/jbb.1000332

  Abstract PDF