Investigating bioequivalence of Diclofenac tablet

In vivo fasted-state bioequivalence study of Diclofenac ER tablets manufactured by Exir Pharmaceutical Co. compared to innovator product

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220211053992N64

Enrollment

Registered

2026-04-25

Start date

2026-05-05

Completion date

Unknown

Last updated

2026-06-01

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 a single oral dose of test product (Diclofenac 100 mg tablet manufactured by Exir Co.) in fasted state. Blood samples will be colle

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney) Age (18-55 years old)

Exclusion criteria

Exclusion criteria: Smoking Pregnancy Alcohol and drug addict History of drug allergy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of drug. Timepoint: Immediately before drug administeration and 0.5-24 hours in predetermined time intervals after drug administration (0, 0.5, 1, 1.5, 2, 2.5, 3,3.5, 4, 4.5, 5, 6, 8, 10, 12, and 24 hours ). 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: Jun 11, 2026