Comparative bioequivalence of 1 mg and 4 mg tacrolimus extended-release tablets: randomized, open label, fully replicate, crossover trials in healthy adult subjects.

Introduction: These studies were planned to establish bioequivalence between two doses (1-mg and 4-mg) of test product (tacrolimus extended-release tablets manufactured by Intas Pharmaceuticals Ltd., India) with reference product (Envarsus XR Methods: These were open-label, randomized, two-treatments, four-periods, two-sequence, oral single-dose, fully-replicate, crossover trials in healthy subjects under fasting and fed conditions. The study included subjects aged 18-45 years, with a body mass index of 18.5-29.9 kg/m Results: The analysis set included a total of 85 (1-mg fasting), 83 (1-mg fed), 85 (4-mg fasting), and 85 (4-mg fed) subjects. Similar demographics were observed across all subjects. Results showed comparable C Conclusion: The developed tacrolimus test product (1-mg and 4-mg) was bioequivalent to the reference product, was well-tolerated, and provided a well-acceptable alternative to the reference product. These studies were performed in healthy individuals, further studies in transplant patient populations to confirm clinical applicability are warranted. CTRI number: These studies have not been registered on the CTRI portal. The studies are routine BA/BE studies conducted in healthy volunteers. As per prevailing regulatory guidance, CTRI registration is not mandatory for such normal BA/BE studies. Additionally, the product under evaluation is already approved worldwide, and the studies do not constitute interventional clinical trials in patients.