IRCT20180620040164N1 IRCT 2018-12-06 Marham daru Bioequivalence study of zolpidem 10 mg tablet in 24 healthy male under fasting conditions Randomized, single-dose, crossover comparative bioavailability study of the Marhamdarou zolpidem versus Stilnoct (Sanofi Company) in 24 healthy males under fasting conditions 2018-01-18 anticipated 24 Complete https://irct.ir/trial/32089 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The sequence of taking test or reference product for each volunteer was determined according to the randomization schedule. The randomization schedule was prepared according to volunteer's allocated number. This number was allocated according to their entrance to volunteers' list in screening day. Bioequivalence comparative bioequivalence study of zolpidem 10 mg tablets of Marhamdarou Co. and Sanofi Co.. Intervention 1: Intervention group (Test): Zolpidem 10 mg Tablet, produced by Marham Darou is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Intervention 2: Control group (Reference): Stilnoct 10 mg Tablet (produced by Sanofi Co.) is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is because of some confedentiality , there is not any decision to issue or publise it.