- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05014490
Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
August 13, 2021 updated by: Darnitsa Pharmaceutical Company
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Kayseri, Turkey, 38038
- Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exib (Test)
A single oral dose of the test product Exib 120 mg etoricoxib film-coated tablets.
|
Oral, COX-2 highly selective, non-steroidal anti-inflammatory generic drug
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Active Comparator: Arcoxia® (Reference)
A single oral dose of the reference product Arcoxia® 120 mg etoricoxib film-coated tablets.
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Oral, COX-2 highly selective, non-steroidal anti-inflammatory innovative drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum plasma concentration (Cmax)
Time Frame: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose.
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The Cmax values are based on the etoricoxib plasma concentration.
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Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose.
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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.
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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.
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Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2021
Primary Completion (Actual)
March 24, 2021
Study Completion (Actual)
March 24, 2021
Study Registration Dates
First Submitted
August 3, 2021
First Submitted That Met QC Criteria
August 13, 2021
First Posted (Actual)
August 20, 2021
Study Record Updates
Last Update Posted (Actual)
August 20, 2021
Last Update Submitted That Met QC Criteria
August 13, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Etoricoxib
Other Study ID Numbers
- ETR01-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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