Cyclizine 50 mg is bioequivalent to the reference.

The objective of this study was to assess the bioequivalence between a fixed-dose combination of tenofovir disoproxil fumarate/lamivudine/efavirenz 300/300/600 mg and the individual innovator products. A randomized, balanced, open-label, two-sequence, two-treatment, two-period, single dose, crossover study in 48 healthy adults was conducted. Dosing was separated by a washout period of 32 days. Twenty-seven blood samples were collected in each period from pre-dose to 72 h post-dose. The data of 45 subjects were analyzed for pharmacokinetics and safety. Ninety percent CIs of geometric mean ratio on C, AUC, and AUC for tenofovir and lamivudine and on C and AUC for efavirenz were within the acceptance criteria (80-125%). For tenofovir disoproxil fumarate, the T, K, and t values for the test and reference products were 1.02 versus 0.91 h, 0.04 versus 0.04/h, 18.67 versus 18.46 h, respectively. For lamivudine, the T, K, and t values were: 1.38 versus 1.30 h, 0.21 versus 0.19/h, 3.44 versus 3.91 h, respectively. For efavirenz, the T values for the test and reference products were 3.71 and 3.65 h, respectively. Both the treatments were well tolerated. Our findings suggest that the tested formulation is bioequivalent to the innovators' formulations, and both treatments were well tolerated.

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 collected up to 36 hours and analyzed for trimetazidine using a validated LC-MS/MS method. Steady-state trimetazidine concentrations were statistically analyzed using SAS ® software for windows (version 9.1). Results: The 90% confidence intervals (CI) for trimetazidine (AUC Tau , and C maxss) were the conventional bioequivalence range of 80.00-125.00%, thus permitting one to conclude for bioequivalence. Furthermore, both formulations were well tolerated and had no-serious adverse event reported. Conclusion: The test and reference formulations of trimetazidine meet the regulatory criteria for bioequivalence both in terms of rate and extent of absorption.

The generic and reference formulations were bioequivalent, as the 90% CIs for C, AUC, and AUC were within the range of 80% to 125%.