bioequivalence study of Escitalopram 10 mg film-coated tablets in 18 healthy male under fasting conditions
- Conditions
- Bioequivalence investigation of the generic (Actoverco.) Escitalopram 10 mg tablet with brand (Cipralex ) Lundbeck Limited 10 mg tablet..
- Registration Number
- IRCT20180620040164N5
- Lead Sponsor
- Actover pharmaceutical co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 18
Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5-30 (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 Escitalopram or inactive Allergy to any medication, substance, or food.
History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, any kind of anemia, asthma, and mental disease.
Muscular trauma 21 days before the beginning of the study.
Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning 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
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).