Bioequivalence investigation of the generic Actover.Domperidone 10 mg F.C. Tablet with brand Motilium® Janssen capsule..
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: (test): Domperidone 10 mg F.C. Tablet, produced by Actover is the test product. In each period, 12 of 24 subjects will be given single oral dose
Sponsors
ACtover Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects should be between 18 – 45 years of age and their Body Mass Index (BMI) should be in the normal range according to the accepted average values between 18.5 and 30 (inclusive), calculated as kg/m2 Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, and laboratory evaluations. Have a ECG and normal vital signs. Subjects who agree with the patient consent form.
Exclusion criteria
Exclusion criteria: History of allergy or iosyncrasy to domperidone or any of the inactive components of the formulation. If you have or have a history of arrhythmia, including tachycardia or ventricular fibrillation, increased QT interval, bradycardia, or heart failure. Identify electrolyte disturbances and water loss due to diarrhea, vomiting or other causes 24 hours before the study. Bleeding or obstruction of the gastrointestinal tract during the last 6 weeks. In case of acute or chronic diseases related to the cardiovascular, respiratory, gastrointestinal, endocrine, blood and kidney or liver failure systems. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. Subjects who have used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during the study period. History of alcohol or drug abuse within 5 years before the start of the study. Heavy drinker of caffeine, grapefruit juice, or caffeinated drinks or who are on a special diet (such as vegetarians) or do exertional physical activity. A history of difficulty with donating blood or donation of more than 450 ml blood within 60 days prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). 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). | — |
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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Aghaei
Noor Research & Development Institute
Outcome results
None listed