Allergic rhinitis, unspecified. Allergic rhinitis, unspecified
Conditions
Interventions
Intervention 1: Intervention group 1: Fexofenadine 30 mg/ 5 ml Suspension , produced by Darou darman Pars. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this
Sponsors
Darou darman Pars Co.
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal 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. Subjects with normal vital signs. Subjects who agree with patient consent form.
Exclusion criteria
Exclusion criteria: • Subjects with known allergy to fexofenadine or any inactive ingredients in the formulation. • Any significant clinical disease or surgical procedure within 4 weeks prior to drug administration; • Any significant clinical abnormality detected during screening; • Abnormal vital signs during screening (Systolic blood pressure less than 90 or more than 140 mm Hg or diastolic blood pressure less than 50 mm Hg or more than 90 mm Hg or Pulse rate less than 50/minute or more than 100/minute). • Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period; • Subjects who has used any drug including Over-The-Counter (OTC) drugs within 7 days prior to the start of the study or prescription drugs (within 14 days) and might need drug intake during study period; • History of alcohol or drug abuse within 2 years before the start of the study; • Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity; • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: 14 blood samples will be withdrawn pre-dose and at 20, 40, 60, 90 and 2, 2/5, 3, 4, 6, 8, 11, 24, 48 hours after intervention.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: 14 blood samples will be withdrawn pre-dose and at 20, 40, 60, 90 and 2, 2/5, 3, 4, 6, 8, 11, 24, 48 hours 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