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
Not Applicable
Recruiting
- Conditions
- 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..
- Registration Number
- IRCT20200407046981N10
- Lead Sponsor
- ???? ???????? ????? ????? ????????
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 24
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
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.