Bioequivalence study of Ondansetron 4 mg film-coated tablet in 24 healthy male under fasting conditions
Not Applicable
- Conditions
- Bioequivalence investigation of the generic (Aburaihan co.) Ondansetron 4 mg tablet with brand (Novartis co.) zofran 4 mg tablet..
- Registration Number
- IRCT20180620040164N2
- Lead Sponsor
- Aburaihan pharmaceutical co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
Healthy subjects with BMI 18.5-30 kg/m2
Not having a history of any significant disease.
Not having any abnormal finding in laboratory examination or during physical examination.
Subjects who agree with patient consent form.
Exclusion Criteria
Known hypersensitivity or idiosyncratic reaction to Ondansetron or any ingredients.
Subjects with BP = 9060 mm/Hg or BP = 140/90 mm/Hg
Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function or a history of TB, epilepsy, asthma (during past 5 years), DM, psychosis or glaucoma.
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: 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 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).