Bioequivalence studies compare both the rate and extent of absorption of various multisource drug formulations 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. Open label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period crossover oral bioequivalence study of Ramipril 5 Mg Tablets supplied by laboratory comparing with that of Tritace® (containing Ramipril 5 Mg) of Sanofi-Aventis Australia pvt Ltd. Australia in healthy, adult , male, 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 in question The aim of a bioequivalence study is to demonstrate equivalence within the acceptance range regarded as clinically relevant. The primary concern in bioequivalence assessment is to limit the risk of erroneously accepting bioequivalence which should not exceed the nominal risk of 5%, and to try to minimize the risk of erroneously rejecting bioequivalence.
