Journal of Bioequivalence & Bioavailability

Milind Gole

Publications

• Research Article
  Comparative Steady State Cross-Over Bioequivalence Study of 35mg Trimetazidine Extended-Release Tablets
  Author(s): Ashish Shedage, Abhishek Khanna, Milind Gole, Shrinivas Purandare and Geena MalhotraAshish Shedage, Abhishek Khanna, Milind Gole, Shrinivas Purandare and Geena Malhotra
  
  Background: Trimetazidine (TMZ), an anti-ischemic drug, protects the myocardial cell from the harmful effects of ischemia. This study is aimed to determine bioequivalence between the test (Trimetazidine ER Tablet of Cipla Limited, India) and the reference (Preductal MR Tablet of Servier, France) products at steady state in 24 healthy adult male volunteers under fed conditions. Method: We conducted a randomized, open-label, balance, two-treatment, two-period, two-sequence, crossover steady state bioequivalence study separated by a washout period of 7 days. Participants were randomly assigned to receive 35mg of trimetazidine either test or reference products twice daily (12 hours interval) after standardized breakfast and dinner on day 1 to day 4, followed by single dose on day 5 after breakfast in each study period. Post-dose blood samples were.. View More»
  DOI: 10.4172/jbb.1000203

  Abstract PDF