Bioequivalence investigation of the generic Hakim.Fexofenadine 180 mg tablet with brand Telfast Sanofi tablet..
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: (test): Fexofenadine 180 mg F.C. tablet, produced by Hakim is the test product. In each period, 12 of 24 subjects will be given single oral dose
Sponsors
Hakim pharmaceutical 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) 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Aghaei
Noor Research & Development Institute
Outcome results
None listed