Allergy, unspecified, initial encounter. Allergy, unspecified, initial encounter
Conditions
Interventions
Intervention 1: Intervention group: Bilastin 20 mg produced by Koushan Pharmed Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wa
Sponsors
Koushan Pharmed Pharmaceutical Co.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 18– 55 years of age. 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.c 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 the products tested.c Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. Subjects who has used any prescription or OTC drugs 14 days prior to the initiation of study and unable to refrain from the concomitant medications. 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. 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: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 11, 24, 48 and 72 hour after administrating the dosage form. 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: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 11, 24, 48 and 72 hour after administrating the dosage form. 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 and educational institute (Tavan)
Outcome results
None listed