Bioequivalence investigation of the generic (Actoverco.) Metoprolol Succinate 95 mg tablet with brand Beloc-Zok® Recordati Pharma GmbH ER 95 mg tablet..
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: (test): Metoprolol Succinate 95 mg tablet, produced by Actoverco. is the test product. In each period, 12 of 24 subjects will be given single or
Sponsors
Actover pharmaceutical co.
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 18 – 40 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 vital signs. Subjects who agree with patient consent form.
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Metoprolol succinate or inactive ingredients. History or current bronchial asthma. 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