Allergic rhinitis, unspecified. Allergic rhinitis, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Fexofenadine 30 mg/ 5 ml Suspension , produced by Darou ?Afshan Shayegan is the test product. In each period, 12 of 24 subjects will be given single oral dose of t
Sponsors
Darou Afshan Shayegan Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Healthy subjects between 18 – 55years of age Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 kg/m2. Subjects with normal vital signs. Subjects who agree with patient consent form.
Exclusion criteria
Exclusion criteria: Subjects with known allergy to the study drug Systolic blood pressure less than 90 or more than 140 mm Hg Diastolic blood pressure less than 50 mm Hg or more than 90 mm Hg 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; History of alcohol or drug abuse Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
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 Timepoint: 14 blood samples will be withdrawn pre-dose and at 20, 40, 60, 90 and 2, 2/5, 3, 4, 6, 8, 11, 24, 48 hours after intervention.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 Timepoint: 14 blood samples will be withdrawn pre-dose and at 20, 40, 60, 90 and 2, 2/5, 3, 4, 6, 8, 11, 24, 48 hours after intervention.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 ContactBehzad Montaha Sangari
Noor Research & Development Institute
Outcome results
None listed