In vivo Bioequivalence study of Rosuvastatin tablet

In vivo fasted-state bioequivalence study of Rosuvastatin 40 mg tablet manufactured by Sobhan Pharmaceutical Co. compared to innovator product

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220211053992N33

Enrollment

Registered

2024-06-09

Start date

2024-06-21

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

In the present study, the products will be administered to healthy volunteers..

Interventions

Intervention 1: Intervention group: Intervention group will receive one tablets of test product (Rosuvastatin 40 mg tablet manufactured by Sobhan Co.) in fasted state. Blood samples will be collected

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