Journal of Bioequivalence & Bioavailability

Raghu Naidu

Publications

• Research Article
  Bioequivalence of Two Formulations of Salmeterol Xinafoate/Fluticasone Propionate HFA pMDI in Healthy Volunteers
  Author(s): Muneesh Garg, Raghu Naidu, Amolkumar Birhade, Krishnan Iyer, Ratnakar Jadhav, Juliet Rebello, Nazma Morde, Mayuri Mangale and Bill Brashier Muneesh Garg, Raghu Naidu, Amolkumar Birhade, Krishnan Iyer, Ratnakar Jadhav, Juliet Rebello, Nazma Morde, Mayuri Mangale and Bill Brashier
  
  In the treatment of asthma, salmeterol xinafoate and fluticasone propionate are known to be effective and well accepted. These studies determined the bioequivalence between the test and reference formulations of salmeterol xinafoate/fluticasone propionate HFA pMDI, in healthy volunteers. Four pharmacokinetic studies were executed with two high strength (25/250 mcg per actuation) and two low strength (25/125 mcg per actuation) for the test and reference formulation. Mostly, the evaluation was based on single dose, randomized, crossover with a minimum washout period of 14 days. Out of the four studies (two for each strength) two also evaluated as pulmonary deposition by blocking gastrointestinal absorption using charcoal administration. Examinations for safety included monitoring of adverse events and vital signs along with clinical laboratory assessments. A validated LC-MS/MS technique.. View More»
  DOI: 10.4172/jbb.1000359

  Abstract PDF