Bioequivalence study of Metoprolol succinate 95 mg ER tablets in 24 healthy male under fasting conditions

Not Applicable

Completed

• Conditions: Bioequivalence investigation of the generic (Actoverco.) Metoprolol Succinate 95 mg tablet with brand Beloc-Zok® Recordati Pharma GmbH ER 95 mg tablet..

• Registration Number: IRCT20180620040164N11
• Lead Sponsor: Actover pharmaceutical co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 24

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

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

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).