Healthy Volunteers Clinical Trial
Official title:
A Randomized, Single Dose, Open Label, Bioequivalence Study of Tacrolimus Capsules 1 mg in Normal Healthy Male Subjects Under Fasting Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 1 mg, manufactured by Astellas Pharma, Inc., USA in 36 normal, healthy, adult, male subjects under fasting condition.
Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to dose administration and for at least 4 hours post dose. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post dose in each period. A total of 23 blood samples will be withdrawn for pharmacokinetic profiling. The whole blood concentrations of Tacrolimus will be measured by a validated LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf. ;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
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