In vivo bioequivalence study of Metoprolol Succinate 47.5 mg Extended Release Tablets of the Test (TEDAPROL® 47.5 mg, Tablets, Tehran darou, Iran)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N168

Enrollment

Registered

2026-01-15

Start date

2026-03-21

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In this study the , the disease is not investigated , bioequivalence of test and brand drug will be evaluated..

Interventions

Intervention 1: First intervention group: Single-dose of Metoprolol Succinate 47.5 mg Extended Release Tablets of Tehran darou in the first period. Cross-over design with one week washing period. Afte

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health(liver, heart, kidney) Body mass index(18-30) Informed consent Age(18-55)

Exclusion criteria

Exclusion criteria: Afflicted by special disease Having allergy to study drug Simultaneous use of the drug used

Design outcomes

Primary

Measure	Time frame
Plasma concentration of the drug. Timepoint: 0, 1 ,2 , 2.5 , 3 , 3.5 , 4 , 4.5, 5 , 5.5 , 6 , 7 , 8 , 9 , 10 , 12 , & 24h after drug administration. Method of measurement: High performance liquid chromatography whit mass spectrophotometry detector.	—

Secondary

Measure	Time frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

shokri.j@gmail.com+98 41 3661 4125

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026