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Bioequivalence study of Celecoxib 200 mg capsule

In vivo fasted-state bioequivalence study of Celecoxib 200 mg capsule manufactured by Reyhaneh pharmaceutical Co. compared to innovator product

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210519051345N94
Enrollment
24
Registered
2026-01-29
Start date
2026-02-09
Completion date
Unknown
Last updated
2026-02-02

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 (Celecoxib 200 mg capsule manufactured by Rayhane Co.) in fasted state. Blood samples will be col

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Plasma concentration of drug. Timepoint: Before drug administration and in the following determined timepoints after drug administration in each period: 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours. 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 7, 2026