IRCT20200407046981N10 IRCT 2021-06-22 شرکت داروسازی رازان فارمد ایرانیان Bioequivalence of a New Generic Formulation of Domperidone 1 mg/ml (200 mL) suspension produced by Razan pharmed Iranian pharmaceutical Co versus Motilium® after single dose administration to healthy volunteers Randomized, single-dose, crossover comparative bioequivalence study of the Domperidone suspension 1 mg/ml (200 mL) produced by Razan pharmed Iranian pharmaceutical Co versus Motilium® (Janssen company) in 24 healthy males under fasting conditions 2021-07-06 anticipated 24 Complete https://irct.ir/trial/56827 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Randomization description: Individuals will be recruited with advertising. 24 volunteers will be allocated to two sequences randomly by lottery method.The number was allocated according to their entrance to volunteers' list in screening day. Bioequivalence In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Domperidone suspension of test and reference in healthy volunteers.. Intervention 1: Intervention group (Test): Domperidone Suspension 1 mg/mL produced by Razan Pharmed Iranian is the test product. In each period, 12 of 24 subjects will be given 20 cc of single oral dose of this product. In the second period, after washout, this group (test) will be in the reference group and will use brand drug (Motilium). Intervention 2: Intervention group (Reference): Domperidone Suspension 1 mg/mL (Motilium), produced by Janssen Company is the test product. In each period, 12 of 24 subjects will be given 20 cc of single oral dose of this product. In the second period, after washout, this group (Reference) will be in the test group and will use domestic Domperidone Suspension. 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 There is no further information