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..
Conditions
Interventions
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 do
Sponsors
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Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: The weight limit for each volunteer is between 60 and 100 kg. Only non-smokers are allowed to participate. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Domperidone or any ingredients. Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg. Regular smoker who smokes more than ten cigarettes daily. Taking any medicine during two week before dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and48 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS). | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Area Under the Concentration-Time Curve). Timepoint: During 2 months after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hamed Hamishehkar
Tabriz University of Medical Sciences
Outcome results
None listed