This study compares the safety and pharmacokinetics parameters of Cinacalcet Hydrochloride Tablets 90mg with the innovator (reference) product, on the basis that if two formulations exhibit similar drug concentration-time profiles in the blood/plasma, they should exhibit similar therapeutic effects. An open label, balanced, analyst blind, randomized, two-treatment, two-period, two sequence, single dose, crossover oral bioequivalence study of Cinacalcet Hydrochloride Tablets 90mg manufactured by Macleods Pharmaceuticals Ltd., India comparing with Sensipar�¯�£�ª (Cinacalcet Hydrochloride) Tablets 90mg manufactured by Amgen USA Inc. on 24 + 4 (standby) healthy, adult, human subjects under fed conditions. To monitor the safety and tolerability of a single dose of the test product as compared to the reference product in healthy adult male human subjects under fed condition. In the following sections, requirements for the design and conduct of comparative bioavailability studies are formulated. Investigator(s) should have appropriate expertise, qualifications and competence to undertake a proposed study and is familiar with pharmacokinetic theories underlying bioavailability studies. The design should be based on a reasonable knowledge of the pharmacodynamics and/or the pharmacokinetics of the active substance. The aim of a bioequivalence study is to demonstrate equivalence within the acceptance range regarded as clinically relevant. In conclusion, the test formulation is bioequivalent to the reference in terms of both the rate and extent of absorption. Both the formulations are well tolerated following a single dose administration of the investigational product. No serious clinical adverse events causing death, disability, hospitalization, or dropouts of the subjects were encountered.
