bioequivalence study of Fexofenadine 180 mg tablets in 24 healthy male under fasting conditions
- Conditions
- Bioequivalence investigation of the generic Hakim.Fexofenadine 180 mg tablet with brand Telfast Sanofi tablet..
- Registration Number
- IRCT20180620040164N7
- Lead Sponsor
- Hakim pharmaceutical Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 24
Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) 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.
Subjects with normal vital signs.
Subjects who agree with patient consent form.
Known hypersensitivity or idiosyncratic reaction to Fexofenadine or inactive ingredients.
Clinically significant illnesses or surgery within 4 weeks of the administration of study medication.
Any clinically significant abnormality found during medical screening.
Vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90; or heart rate less than 50 bpm or over 100 bpm) at screening.
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
Subjects who has used any drug including prescription drugs (within 14 days) or Over-The-Counter (OTC) drugs within 7 days prior to the start of the study and might need drug intake during study period.
History of alcohol or drug abuse.
A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.
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).