In vivo Bioequivalence study of Bisoprolol H tablet

In vivo Bioequivalence study of Bisoprolol H (10/25) tablet manufactured by AaniDarman Pharmaceutical Co. Compared to innovator Product

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220211053992N27

Enrollment

Registered

2024-03-15

Start date

2024-04-13

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Volunteers are Healthy people..

Interventions

Intervention 1: Intervention group: Intervention group will receive a single oral dose of test product (Bisoprolol H(10/25) tablet manufactured by AaniDarman Co., Iran) in fasted state. Blood samples

Eligibility

Sex/Gender

All

Age

18 Years to 59 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney diseases) Age between 18 to 59 years

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular, liver, and kidney disease Pregnancy Alcohol and drug addiction History of drug allergy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of drug. Timepoint: 0.5-48 hours in predetermined time intervals after drug administration. Method of measurement: HPLC (High performance liquid chromatography).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Valizadeh

Tabriz University of Medical Sciences

valizadehh@gmail.com+98 41 3334 8801

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026