Bioequivalence study of scored F.C.Tablet 20 mg paroxetine Hydrochloride (Rexopan®) manufactured by Tadbir Kalaye Jam company

Bioequivalence study of scored F.C.Tablet 20 mg paroxetine Hydrochloride (Rexopan®) manufactured by Tadbir Kalaye Jam company in comparison with Paxil® 20 mg Apotex company on healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240803062623N13

Enrollment

Registered

2025-04-13

Start date

2025-05-22

Completion date

Unknown

Last updated

2025-07-21

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: Intervention group: Single-dose of the test drug F.C.Tablet 20 mg paroxetine Hydrochloride (Rexopan®) manufactured by tadbir kalaye jam company. Intervention 2: Control group: Single

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: Smoking history of cardiovascular disease history of liver & kidney disease Alcohol & Drug addiction Hypersensitivity to the drug Pregnancy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of the drug. Timepoint: 0-1-2-3-3.5-4-4.5-5-5.5-6-6.5-8-10-12-24-48-72-96h after drug adminstration. Method of measurement: HPLC-MS/MS.	—

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 ContactMohammad Ali Karkhaneh Yousefi

Tadbir Kalaye Jam co.

yousefi@tadbirkala.com+98 21 8866 8700

Outcome results

None listed

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