BioequivalencePhase 1NCT05014490
Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
A Phase 1 study testing Exib 120 mg etoricoxib film-coated tablets and Arcoxia® 120 mg etoricoxib film-coated tablets in people with Bioequivalence and Healthy Subjects, run by Darnitsa Pharmaceutical Company at 1 site in Turkey (Türkiye).
Trial summary
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product Arcoxia® 120 mg etoricoxib… 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
- Bioequivalence, Healthy Subjects
- What is being tested?
- Exib 120 mg etoricoxib film-coated tablets and Arcoxia® 120 mg etoricoxib film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2021to 24 Mar 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Caucasian males.
- Subjects aged between 18 and 55 years (inclusively) at the date of signing ICF which was defined as the beginning of the screening period.
- Subjects with a BMI at screening within 18.5 to 30.0 kg/m2, inclusively.
- Willingness to adhere to the protocol requirements and to provide written, personally signed, and dated ICF to participate in the study before the start of any study-related procedures.
- Availability for the entire duration of the study.
- Motivated subjects with absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee.
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- Satisfactory medical assessment at screening with no clinically relevant abnormalities as determined by medical history, physical examination, ECG, and clinical laboratory evaluation (haematology, biochemistry and urinalysis) that were reasonably likely to interfere with the subject's participation in or ability to complete the study as assessed by the Investigator.
- Subjects were required to agree to abstain from xanthine-containing products (i.e. coffee, tea, cola, energy drinks, chocolate, etc.) from 48 hours prior to the first study drug administration until the end of confinement.
- Subjects were required to agree to abstain from poppy seed-containing products from 48 hours prior to the first study drug administration until the end of confinement.
- Subjects were required to agree to abstain from alcohol from 48 hours prior to the first study drug administration until the end of study.
- Subjects were required to abstain and agree to continue to abstain from St John's Wort, vitamins and herbal remedies from 2 weeks prior to the first study drug administration until the end of confinement.
- Subjects were required to abstain and agree to continue to abstain from beverages or food containing orange, grapefruit or pomelo from 2 weeks prior to the first study drug administration until the end of confinement.
- Subjects had to agree to use medically acceptable methods of contraception during the study and for 30 days after the end of the study. Medically acceptable methods of contraception included using a condom with a female partner of childbearing potential who is using oral contraceptives, hormonal patch, implant or injection, intrauterine device, or diaphragm with spermicide. Complete abstinence alone could be used as a method of contraception.
Who cannot join
- History of significant hypersensitivity to etoricoxib or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (such as angioedema) to any drug.
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
- History of major surgery of the gastrointestinal tract except for appendectomy.
- History of significant gastrointestinal, liver or kidney disease that might affect the drug BA.
- Presence of significant cardiovascular, respiratory, genitourinary, musculoskeletal, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
- Presence of respiratory infection symptoms (COVID-19 infection symptoms) like fever, dry cough, nasal congestion or sore throat.
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- Having COVID-19 infection or having been in contact to people with known COVID-19 infection in the last 14 days.
- Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch, electronic cigarettes) within 6 months prior to Day 1 Period 1.
- History of controlled or uncontrolled hypertension or clinically relevant Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and/or Heart Rate (HR) readings outside the normal ranges at screening (Day -3) or prior to drug administration on Day 1 Period 1. Normal ranges are defined below:
- SBP: 90 to 140 mmHg
- DBP: 60 to 90 mmHg
- HR: 50 to 100 beats/min
- Forehead body temperature readings outside the range of 35.5 to 37.4 ºC at screening (Day -5, -4, -3, -2, -1) or prior to the first drug administration.
- Any planned surgery involving general, spinal or epidural anaesthesia from 3 months prior to Day 1 Period 1 to 7 days after last dosing.
- Known presence of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
- Any clinically significant illness within 30 days prior to Day 1 Period 1.
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and Human Immunodeficiency Virus (HIV) antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampicin) within 30 days prior to Day 1 Period 1.
- Use of Over the Counter (OTC) medications within 7 days prior to Day 1 Period 1. It was specifically reminded that this included cold preparations, Acetylsalicylic Acid (ASA), natural products used for therapeutic benefits and antacid preparations.
- Intake of any prescription medication within 30 days prior to Day 1 Period 1.
- Maintenance therapy with any drug or significant history of drug dependency.
- Alcohol abuse, i.e. regular use of more than 10 units per week (one unit of alcohol equals 250 mL of beer, 125 mL of wine or 25 mL of spirits), a history of alcoholism or recovered alcoholics.
- Positive alcohol, drugs of abuse or cotinine results at screening (Day -1).
- Positive result on Day -5 and/or Day -2 of screening on COVID-19 RT-PCR test.
- History of drug abuse or use of illegal drugs: use of soft drugs (e.g. marihuana) within 6 months of screening or hard drugs (e.g. amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opioids) within 1 year of screening.
- A positive Human Immunodeficiency Virus antibody (HIV-Ab) screen, Hepatitis B surface antigen (HBsAg) or Hepatitis C Virus (HCV) tests.
- Use of an investigational product within 60 days prior to Day 1 Period 1 or active enrolment in another drug or vaccine clinical study.
- Use of depot injectable solutions with a half-life of >1 week within 6 months prior to Day 1 Period 1.
- Subjects previously randomised in this study.
- An inability to follow a standardised diet and meal schedule or inability to fast, as required during the study.
- Donation of blood (at least 100 mL) or plasma by plasmapheresis within 30 days prior to Day 1 Period 1.
- Volunteers who reported difficulty swallowing tablets as a whole.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)
Kayseri, 38038
About this study
Official title: Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Exib 120 mg Etoricoxib Film-coated Tablets (PrJSC "Pharmaceutical Firm "Darnitsa") and Arcoxia 120 mg Etoricoxib Film-coated Tablets (Merck Sharp&Dohme B.V.) in Healthy, Adult Volunteers Under Fasting Conditions
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product Arcoxia® 120 mg etoricoxib film-coated tablets, Marketing Authorisation Holder: UAB "Merck Sharp\&Dohme", Lithuania) in healthy volunteers.
- Conditions
- Bioequivalence, Healthy Subjects
- Being tested
- Exib 120 mg etoricoxib film-coated tablets, Arcoxia® 120 mg etoricoxib film-coated tablets
- Keywords
- bioequivalence, etoricoxib, healthy subjects, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exib 120 mg etoricoxib film-coated tabletsDrug
Oral, COX-2 highly selective, non-steroidal anti-inflammatory generic drug
Arcoxia® 120 mg etoricoxib film-coated tabletsDrug
Oral, COX-2 highly selective, non-steroidal anti-inflammatory innovative drug
| Study group | Role | What they receive |
|---|---|---|
| Exib (Test) | Experimental | A single oral dose of the test product Exib 120 mg etoricoxib film-coated tablets. Receives: Drug: Exib 120 mg etoricoxib film-coated tablets |
| Arcoxia® (Reference) | Active comparator | A single oral dose of the reference product Arcoxia® 120 mg etoricoxib film-coated tablets. Receives: Drug: Arcoxia® 120 mg etoricoxib film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
The Cmax values are based on the etoricoxib plasma concentration.
Measured: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose.
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
The AUC0-t is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (t) and is based on the etoricoxib plasma concentration.
Measured: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start24 Feb 2021
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BioequivalenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-period, two-sequence, two-way crossover single dose study
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darnitsa Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anapharm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014490
- Sponsor's protocol ID
- ETR01-E
- Status last verified
- Nov 2024
- First submitted
- 3 Aug 2021
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Exib 120 mg Etoricoxib Film-coated Tablets (PrJSC "Pharmaceutical Firm "Darnitsa") and Arcoxia 120 mg Etoricoxib Film-coated Tablets (Merck Sharp&Dohme B.V.) in Healthy, Adult Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05014490
- Acronym / sponsor ID
- ETR01-E
- Conditions
- Bioequivalence, Healthy Subjects
- Keywords
- bioequivalence, etoricoxib, healthy subjects, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Darnitsa Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Anapharm
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product Arcoxia® 120 mg etoricoxib film-coated tablets, Marketing Authorisation Holder: UAB "Merck Sharp\&Dohme", Lithuania) in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-period, two-sequence, two-way crossover single dose study
| Arm | Type | Receives |
|---|---|---|
| Exib (Test) | Experimental | Drug: Exib 120 mg etoricoxib film-coated tabletsA single oral dose of the test product Exib 120 mg etoricoxib film-coated tablets. |
| Arcoxia® (Reference) | Active comparator | Drug: Arcoxia® 120 mg etoricoxib film-coated tabletsA single oral dose of the reference product Arcoxia® 120 mg etoricoxib film-coated tablets. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Caucasian males.
- Subjects aged between 18 and 55 years (inclusively) at the date of signing ICF which was defined as the beginning of the screening period.
- Subjects with a BMI at screening within 18.5 to 30.0 kg/m2, inclusively.
- Willingness to adhere to the protocol requirements and to provide written, personally signed, and dated ICF to participate in the study before the start of any study-related procedures.
- Availability for the entire duration of the study.
Key exclusion criteria (31 listed)
- History of significant hypersensitivity to etoricoxib or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (such as angioedema) to any drug.
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
- History of major surgery of the gastrointestinal tract except for appendectomy.
- History of significant gastrointestinal, liver or kidney disease that might affect the drug BA.
- Presence of significant cardiovascular, respiratory, genitourinary, musculoskeletal, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
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 |
|---|---|---|
| Exib 120 mg etoricoxib film-coated tabletsOral, COX-2 highly selective, non-steroidal anti-inflammatory generic drug | Drug | Exib (Test) |
| Arcoxia® 120 mg etoricoxib film-coated tabletsOral, COX-2 highly selective, non-steroidal anti-inflammatory innovative drug | Drug | Arcoxia® (Reference) |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose.
The Cmax values are based on the etoricoxib plasma concentration.
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
Time frame: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose.
The AUC0-t is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (t) and is based on the etoricoxib plasma concentration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Exib 120 mg etoricoxib film-coated tablets and Arcoxia® 120 mg etoricoxib film-coated tablets in people with Bioequivalence and Healthy Subjects, run by Darnitsa Pharmaceutical Company at 1 site in Turkey (Türkiye).
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 13 inclusion and 31 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 29 Nov 2024. 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 Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose.). The study lists 2 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 29 Nov 2024.