Bioequivalence study of Metoprolol Succinate ER 23.75 mg Extended Release Tablet (Saponine Iran) versus Toprol XL 25 (Arelez pharmaceuticals) Tablet after single oral dosing in healthy volunteers

Not Applicable

Conditions: Bioequivalence study of Metoprolol Succinate ER 23.75 mg Extended Release Tablet (Saponine Iran) versus Toprol XL 25 (Arelez pharmaceuticals) Tablet after single oral dosing in healthy volunteers.

Registration Number: IRCT20220111053692N11

Lead Sponsor: Saponine Pharmaceutical Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Male

Target Recruitment: 24

Inclusion Criteria

18 to 55 years old
Weight in range of 10 % proper body weight
All volunteers should be in a good health condition on the basis of medical history ,physical examination , routine blood test.
Possessing negative test for hepatitis B surface antigen (HBs-Ag), Antihepatitis-C antibody (anti-HCV) and anti-HIV.
Gender: male

Exclusion Criteria

Volunteers with hypersensitivity to Metoprolol Succinate were excluded.
Those with known history of drug abuse. alcohol consumer or cigarette smokers.
Taking medications that have drug interactions with Metoprolol Succinate until one month before studying.
Disinclination to take the test
Blood donation or blood loss of more than 200 ml in the past month

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Drug concentration in plasma samples. Timepoint: In times 0 ? 1? 2? 2/5 ? 3? 3/5? 4? 4/5 ? 5? 5/5 ? 6? 6/5? 7? 7/5? 8? 9? 10? 18? 24? 30? 36 ? 48 Hours after the start of the intervention. Method of measurement: chromatography.

Secondary Outcome Measures