Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers

NCT05014490 | Completed Phase 1 Results

• 1 other identifier: ETR01-E
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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 film-coated tablets, Marketing Authorisation Holder: UAB "Merck Sharp\&Dohme", Lithuania) in healthy volunteers.

Conditions

Bioequivalence; Healthy Subjects

Keywords

bioequivalence; etoricoxib; healthy subjects; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration (Cmax)

  The Cmax values are based on the etoricoxib plasma concentration.

  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.

  Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose.

Study Arms (2)

Exib (Test)

EXPERIMENTAL

A single oral dose of the test product Exib 120 mg etoricoxib film-coated tablets.

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.

Drug: Arcoxia® 120 mg etoricoxib film-coated tablets

Interventions

Exib 120 mg etoricoxib film-coated tablets DRUG

Oral, COX-2 highly selective, non-steroidal anti-inflammatory generic drug

Exib (Test)

Arcoxia® 120 mg etoricoxib film-coated tablets DRUG

Oral, COX-2 highly selective, non-steroidal anti-inflammatory innovative drug

Arcoxia® (Reference)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Darnitsa Pharmaceutical Company: lead
• Anapharm: collaborator

Study Sites (1)

Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)

Kayseri, 38038, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Etoricoxib

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Andrii Doroshenko, PhD, MD
• Organization: PrJSC "Pharmaceutical Firm "Darnytsia"

a.doroshenko@darnytsia.ua

+38 044 207 73 53

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-period, two-sequence, two-way crossover single dose study

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 20, 2021
• Study Start: February 24, 2021
• Primary Completion: March 24, 2021
• Study Completion: March 24, 2021
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)