This study will be performed to compare the pharmacokinetics and invivo parameters of Celecoxib 200 mg formulation as a test product with Celebrex® tablet formulation as a reference product and to evaluate the biocompatibility of these two formulations.
Design
Non-blinded, randomized, crossover in vivo bioequivalence study in 24 healthy subjects under fasting conditions. Block randomization for a treatment sequence of Test/Reference or Reference/Test is used.
Settings and conduct
In each period, volunteers will receive a single dose of the treatment in the Noor Research and Development Institute (Tarasht, Tehran). 2 dosing periods will be separated by a 7-day washout period.
Participants/Inclusion and exclusion criteria
Healthy subjects (male) between 18–55 years of age and Body Mass Index (BMI) 18.5 - 30 (inclusive); Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, and laboratory evaluations; Subjects with normal vital signs; Known hypersensitivity to Aprepitant or its analogs; Smoking more than ten cigarettes per day and could not tolerate cigarette cessation during each clinical period.
Intervention groups
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 this product. Intervention group (Reference): Celebrex® capsule, produced by Pfizer is the reference product. In each period, 12 of 24 subjects will be given a single oral dose of this product.
Main outcome variables
Peak Plasma Concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180620040164N106
Registration date:2026-05-10, 1405/02/20
Registration timing:prospective
Last update:2026-05-10, 1405/02/20
Update count:0
Registration date
2026-05-10, 1405/02/20
Registrant information
Name
Behzad Montaha Sangari
Name of organization / entity
Noor research and educational institute (Tavan)
Country
Iran (Islamic Republic of)
Phone
+98 21 6600 7026
Email address
info@tavaninstitute.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-26, 1405/04/05
Expected recruitment end date
2026-07-03, 1405/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of Celecoxib 200 mg Capsule of Dorsa Pharmaceutical Doroxib and Celebrex® of Pfizer
Public title
Bioequivalence study of Celecoxib 200 mg Capsule in 24 healthy subjects under fasting conditions
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization schedule will be generated with https://www.sealedenvelope.com/simple-randomiser/v1/lists. A 2*2 block randomization list is created. We have 12 blocks and within each two volunteer numbers (allocated after screening) for all 24 volunteers. According to this list, a treatment sequence of Test/Reference or Reference/Test will be given to each volunteer.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2026-05-04, 1405/02/14
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1405.064
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
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 outcomes
1
Description
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)
Intervention groups
1
Description
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 this product.
Category
Treatment - Drugs
2
Description
Intervention group (Reference): Celebrex® capsule, produced by Pfizer is the reference product. In each period, 12 of 24 subjects will be given a single oral dose of this product.