Investigating Bioequivalence of Sertraline Tablet

In vivo Bioequivalence study of Sertraline 100 mg tablet manufactured by Reyhaneh Pharmaceutical Co. Compared to innovator Product Zoloft ®

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220211053992N1

Enrollment

Registered

2022-05-29

Start date

2022-06-21

Completion date

Unknown

Last updated

2022-06-27

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

Conditions

None listed

Interventions

Intervention 1: Intervention group: Intervention group will receive one test drug product manufactured by Reyhaneh Co.. Blood samples will be taken from the volunteers for 72 hours at the mentioned t

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart and Kidney) Age between 18 to 60 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Plasma Drug Concentration. Timepoint: 0.5-72 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