Bioequivalence investigation of the generic (Actoverco.) Montelukast 5 mg chewable tablet with brand (Merck Sharp & Dohme Ltd) SINGULAIR 5 mg chewable tablet..
Conditions
Interventions
Intervention 1: Intervention group: Montelucast 5 mg chewable tablet, produced by Actoverco. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Inte
Sponsors
Actoverco.
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 ECG and vital signs. Subjects who agree with patient consent form.
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to montelukast or inactive ingredients Subjects with a known history of allergic reaction or drug intolerance Dehydration due to diarrhea, vomiting, or another cause in the last 24 hours before the beginning of the first period of the study Subjects with history of psychiatric disorders, convulsions, epilepsy or other neurological disorders Acute and chronic cardiovascular, respiratory, gastrointestinal diseases, neuroendocrine disorders, blood system disorders and renal or hepatic impairment Acute infectious diseases less than 4 weeks prior to the start of the study Surgical interventions on the gastrointestinal tract with the exception of appendectomy Sitting systolic blood pressure 130 mm Hg and/or sitting diastolic blood pressure 90 mm Hg Heart rate 80 beats per minute at screening check-in 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 or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period Subjects who have a history of alcohol or substance abuse within the last 5 years Heavy drinker of alcohol, 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 450 ml blood within 60 days prior to the start of the study History of phenylketonuria
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