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Investigating the in vivo bioequivalence of Celecoxib 100 mg tablet

Fasted-state in vivo bioequivalence study of Celecoxib 100 mg tablet manufactured by Farnoush Daru Teb Co. compared with innovator product

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210519051345N15
Enrollment
24
Registered
2022-08-17
Start date
2022-09-16
Completion date
Unknown
Last updated
2022-08-29

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 test drug product. Blood samples will be collected for48 hours at the mentioned times after drug administration and the con

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Plasma concentration of drug. Timepoint: 0.5-48 hours in predetermined time intervals after drug administration (0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 h). Method of measurement: HPLC (High performance liquid chromatography).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Zakeri-Milani

Tabriz University of Medical Sciences

pzakeri@tbzmed.ac.ir+98 41 3334 8801

Outcome results

None listed

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