Bioequivalence of Duloxetine

Single-dose bioequivalence studies of Duloxetine (60 mg) in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210201050197N1

Enrollment

Registered

2021-02-19

Start date

2021-02-26

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

Healthy subjects.

Interventions

Intervention 1: Intervention group: Receiving Iranian medicine (generic product): In this group, each volunteer receives a 60 mg Duloxetine tablets made by Aria Company during a treatment period. Afte

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy volunteer Age: 18-50 year

Exclusion criteria

Exclusion criteria: History of liver, kidney and cardiovascular diseases that can affect drug clearance from body History of taking any medication in the last two weeks Creatinine above 2

Design outcomes

Primary

Measure	Time frame
Plasma drug concentration. Timepoint: 1? 2? 3? 4? 5, 5.5, 6? 6.5, 7, 8? 10? 12? 24? 32, 48 hours. Method of measurement: High performance liquid chromatography (HPLC) method.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh Haeri

Shahid Beheshti University of Medical Sciences

a_haeri@sbmu.ac.ir+98 21 8820 0212

Outcome results

None listed

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