Bioequivalence study of Montelukast 5 mg chewable tablets in 24 healthy male under fasting conditions
- Conditions
- Bioequivalence investigation of the generic (Actoverco.) Montelukast 5 mg chewable tablet with brand (Merck Sharp & Dohme Ltd) SINGULAIR 5 mg chewable tablet..
- Registration Number
- IRCT20180620040164N3
- Lead Sponsor
- Actoverco.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
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.
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 < 100 mm Hg or > 130 mm Hg and/or sitting diastolic blood pressure < 70 mm Hg or > 90 mm Hg
Heart rate <60 or >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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).