Bioequivalence study of Celecoxib 200 mg Capsule in 24 healthy subjects under fasting conditions

Comparative bioequivalence study of Celecoxib 200 mg Capsule of Dorsa Pharmaceutical Doroxib and Celebrex® of Pfizer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180620040164N106

Enrollment

Registered

2026-05-10

Start date

2026-06-26

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

Pain. Pain, unspecified

Interventions

Intervention 1: Intervention group (test): Celecoxib 200 mg capsule, produced by ?Dorsa Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of th

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy subjects (male) between 18 – 55 years of age Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Subjects with normal vital signs.

Exclusion criteria

Exclusion criteria: History of known sensitivity to the tested products Associated acute or chronic infections Systolic blood pressure less than 90 or more than 140 mm Hg and diastolic less than 50 or more than 90 mm Hg. Heart rate less than 50 or more than 100 beats per minute Smoking more than 10 cigarettes a day History of alcohol or drug abuse Loss of more than 500 ml of blood in less than 7 days

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax). Timepoint: 14 blood samples will be withdrawn pre-dose and at 0/5? 1? 1/5? 2? 2/5? 3? 4? 6? 8 ?10? 12? 24? 48 hours after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).	—

Secondary

Measure	Time frame
AUC (Area Under the Concentration-Time Curve). Timepoint: 14 blood samples will be withdrawn pre-dose and at 0/5? 1? 1/5? 2? 2/5? 3? 4? 6? 8 ?10? 12? 24? 48 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehzad Montaha Sangari

Noor Research & Development Institute

info@tavaninstitute.ir+98 21 6600 4027

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026