Healthy SubjectsPhase 1NCT05532280
Bioequivalence Study of Etoricoxib in Healthy Adult Subjects Under Fasting Condition
A Phase 1 study testing Etoricoxib 90 mg film coated tablet and Arcoxia 90 mg film coated tablet in people with Healthy Subjects, run by Future University in Egypt at 1 site in Egypt.
Trial summary
To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Etoricoxib 90 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Etoricoxib 90 mg film coated tablet and Arcoxia 90 mg film coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Dec 2020to 14 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent is obtained for the study.
- Age 18 - 55 years,
- Body mass index between 18.5 and 30 kg/m2
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
- Vital signs without significant deviations.
- All laboratory screening results are within the normal range or clinically non-significant
Who cannot join
- History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk, or interfere with the ability of the subject to complete the study in the investigator's opinion.
- History of significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer.
- Any confirmed significant allergic reactions against any drug or multiple allergies.
- Clinically significant illness 28 days before study phase I.
- Alcohol or any solvent intake.
- Regular use of medication.
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- Positive urine screening of drugs of abuse.
- Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
- History or presence of significant smoking (more than one pack per day of cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
- Blood donation within the past 60 days.
- Participation in another bioequivalence study within 60 days prior to the start of phase I of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Oral Dose, Two-way Crossover, Open-label, Laboratory Blind, Bioequivalence Study Comparing Etoricoxib From Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions
To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Etoricoxib 90 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.
Read the detailed description
Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 14 days.
Etoricoxib plasma concentration was determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.
- Conditions
- Healthy Subjects
- Being tested
- Etoricoxib 90 mg film coated tablet, Arcoxia 90 mg film coated tablet
- Keywords
- Bioequivalence, Randomized, Crossover, Etoricoxib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etoricoxib 90 mg film coated tabletDrug
Also called Test product (T)
an immediate-release tablet containing 90 mg of Etoricoxib
Arcoxia 90 mg film coated tabletDrug
Also called Reference product (R)
an immediate-release tablet containing 90 mg of Etoricoxib
| Study group | Role | What they receive |
|---|---|---|
| Test Product (T) | Experimental | subjects were administered a single tablet of 90 mg Etoricoxib with approximately 240 ml water after an overnight fast of 10 hours Receives: Drug: Etoricoxib 90 mg film coated tablet |
| Reference Product (R) | Active comparator | subjects were administered a single tablet of 90 mg Etoricoxib with approximately 240 ml water after an overnight fast of 10 hours Receives: Drug: Arcoxia 90 mg film coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Cmax is observed at the maximum of Etoricoxib peak concentration
Measured: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
the area under the curve (AUC 0-t)
Cumulative Area Under the Etoricoxib plasma concentration-time Curve calculated from 0 to time of last quantifiable concentration (t last) using the Trapezoidal method
Measured: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
the area under the curve extrapolated to infinity (AUC0-∞)
AUC from Dosing time extrapolated to infinity, based on the last observed concentration
Measured: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
Secondary outcomes (3)
Maximum time (Tmax)
Time until Cmax is reached
Measured: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
Apparent terminal half-life (t½)
the time required for the Etoricoxib plasma concentration to decrease by 50% after the pseudo-equilibrium of distribution has been reached
Measured: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
Apparent elimination rate constant (Kel).
First-order rate constant associated with the terminal (log-linear) portion of the curve
Measured: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start28 Dec 2020
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Masoud, Future University in Egypt
- Investigators
- Hala Masoud, PhD, Principal investigator, Future Research Center (FRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532280
- Sponsor's protocol ID
- COX-B-20-035
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Oral Dose, Two-way Crossover, Open-label, Laboratory Blind, Bioequivalence Study Comparing Etoricoxib From Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05532280
- Acronym / sponsor ID
- COX-B-20-035
- Conditions
- Healthy Subjects
- Keywords
- Bioequivalence, Randomized, Crossover, Etoricoxib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Etoricoxib 90 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.
Detailed description
Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 14 days.
Etoricoxib plasma concentration was determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| Test Product (T) | Experimental | Drug: Etoricoxib 90 mg film coated tabletsubjects were administered a single tablet of 90 mg Etoricoxib with approximately 240 ml water after an overnight fast of 10 hours |
| Reference Product (R) | Active comparator | Drug: Arcoxia 90 mg film coated tabletsubjects were administered a single tablet of 90 mg Etoricoxib with approximately 240 ml water after an overnight fast of 10 hours |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent is obtained for the study.
- Age 18 - 55 years,
- Body mass index between 18.5 and 30 kg/m2
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
- Vital signs without significant deviations.
Key exclusion criteria (11 listed)
- History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk, or interfere with the ability of the subject to complete the study in the investigator's opinion.
- History of significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer.
- Any confirmed significant allergic reactions against any drug or multiple allergies.
- Clinically significant illness 28 days before study phase I.
- Alcohol or any solvent intake.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etoricoxib 90 mg film coated tabletAlso: Test product (T)an immediate-release tablet containing 90 mg of Etoricoxib | Drug | Test Product (T) |
| Arcoxia 90 mg film coated tabletAlso: Reference product (R)an immediate-release tablet containing 90 mg of Etoricoxib | Drug | Reference Product (R) |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
Cmax is observed at the maximum of Etoricoxib peak concentration
the area under the curve (AUC 0-t)
Time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
Cumulative Area Under the Etoricoxib plasma concentration-time Curve calculated from 0 to time of last quantifiable concentration (t last) using the Trapezoidal method
the area under the curve extrapolated to infinity (AUC0-∞)
Time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
AUC from Dosing time extrapolated to infinity, based on the last observed concentration
3 secondary outcomes
Maximum time (Tmax)
Time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
Apparent terminal half-life (t½)
Time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
Apparent elimination rate constant (Kel).
Time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala Masoud, PhD principal investigator
Future Research Center (FRC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etoricoxib 90 mg film coated tablet and Arcoxia 90 mg film coated tablet in people with Healthy Subjects, run by Future University in Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) (time frame: (Pre-dose) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75. 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.