bioequivalence study of Levodopa 200 mg + Benserazide 50 mg tablets in 24 healthy male under fasting conditions
- Conditions
- Bioequivalence investigation of the generic Abian Pharmed Co. Levodopa 200 mg + Benserazide 50 mg tablet with brand MADOPAR ROCHE tablet..
- Registration Number
- IRCT20180620040164N6
- Lead Sponsor
- Abian Pharmed Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
Healthy subjects (male) between 20– 45years 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 vital signs.
Subjects who agree with patient consent form.
Subjects with known allergy to the products tested.
History of cardiovascular, hepatic, renal, psychiatric, neurologic, hematologic, or metabolic disease
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;
History of alcohol or drug abuse within 2 years before the start of the study;
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).