Abhishek  Khanna
	
					    												
India						                            
                            
						
 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