Bioequivalence Study of Two Formulations of Etoricoxib Tablets 120 mg in Healthy Volunteers Under Fasting Conditions

NCT04830579 | Unknown Phase 1

• 1 other identifier: ETRXB-2020-CPI-FRMT
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Arcoxia®, 120 mg film-coated tablets) or the test (Etoricoxib, 120 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

Conditions

Bioequivalence

Keywords

Etoricoxib; Bioequivalence; Arcoxia

Outcome Measures

Primary Outcomes (2)

• Cmax of etoricoxib in plasma after administration of the test and the reference products.

  Maximum observed concentration in plasma.

  Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 hours after each drug administration.

• AUC0-t of etoricoxib in plasma after administration of the test and the reference.

  Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method

  Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 hours after each drug administration.

Secondary Outcomes (8)

• Tmax of etoricoxib in plasma after administration of the test and the reference products.

  Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 hours after each drug administration.

• TLQC of etoricoxib in plasma after administration of the test and the reference products.

  Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 hours after each drug administration.

• AUC0-INF of etoricoxib in plasma after administration of the test and the reference products.

  Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 hours after each drug administration.

• Residual area of etoricoxib in plasma after administration of the test and the reference products.

  Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 hours after each drug administration.

• Time point where the log-linear elimination phase begins (TLIN) of etoricoxib in plasma after administration of the test and the reference products.

  Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 hours after each drug administration.

Study Arms (2)

Sequence TR

OTHER

17 subjects assigned to the sequence TR will receive a single 120 mg dose of the test product Etoricoxib (1 x 120 mg tablet), marked as T in the sequence, in Period 1 and a single 120 mg dose of the reference product Arcoxia® (1 x 120 mg tablet), marked as R in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.

Drug: Etoricoxib film-coated tablet 120 mg; Drug: Arcoxia® film-coated tablet 120 mg

Sequence RT

OTHER

17 subjects assigned to the sequence RT will receive a single 120 mg dose of the reference product Arcoxia® (1 x 120 mg tablet), marked as R in the sequence, in Period 1 and a single 120 mg dose of the test product Etoricoxib (1 x 120 mg tablet), marked as T in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.

Drug: Etoricoxib film-coated tablet 120 mg; Drug: Arcoxia® film-coated tablet 120 mg

Interventions

Etoricoxib film-coated tablet 120 mg DRUG

Etoricoxib is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 120 mg of etoricoxib.

Also known as: The test product

Sequence RT; Sequence TR

Arcoxia® film-coated tablet 120 mg DRUG

Arcoxia® is manufactured by Frosst Iberica SA, Spain. Each tablet contains 120 mg of etoricoxib.

Also known as: The reference product

Sequence RT; Sequence TR

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy caucasian men or women aged between 18 to 45 years 2. Verified diagnosis "healthy" according to the anamnesis data and the results of standard clinical, laboratory and instrumental examination methods, physical examination and anamnestic examination 3. The results of an X-ray or fluorographic examination of the chest organs within the normal range (the results of an examination carried out within 12 months before the start of the study may be provided) 4. Body mass index 18.5-30 kg/m² 5. For female subject:
• the results of the examination of the mammary glands (palpation or mammography) within the normal range according to the data obtained within 12 months before the start of the study,
• Non-breastfeeding women,
• Non-pregnant women (negative pregnancy test),
• If subject is a female and is of childbearing potential, she should be practicing an acceptable method of birth control for the duration of the study (the entire time from at least 14 days before taking the drug in the first period and within 14 days after taking the drug in the second period): sexual continence, or condom + spermicide, or diaphragm + spermicide. Intrauterine contraception is also a reliable method of contraception, installed at least 4 weeks before taking the study drugs in the first period,
• women who are not using acceptable methods of contraception if they are considered incapable of childbearing can participate in the study: women who have undergone a hysterectomy or tubal ligation, women with a clinical diagnosis of infertility, and women who are in menopause (at least a year without menstruation in the absence of alternative medical conditions),
• in case of using contraceptives (injectable and oral hormonal contraceptives, subcutaneous hormonal implants or intrauterine hormonal therapeutic systems), the latter should be canceled at least 60 days before taking the drug in the first period; 6. Consent to use a double barrier method of contraception (condom + spermicide) or sexual continence, as well as consent not to take part in sperm donation from the moment of taking the drug in the first period, during the entire study and within 14 days after taking the drug in the second period research 7. Subjects are able to understand the requirements of the study, to sign a written informed consent, and also to accept all the restrictions imposed during the course of the study, and to agree to return for the required investigations
• Burdened allergic history, hypersensitivity to etoricoxib or excipients that are part of any of the investigational drugs, or intolerance to these components.
• Complete or incomplete combination of bronchial asthma, acute rhinitis, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or intolerance to other NSAIDs (including a history).
• Increased risk of complications from the gastrointestinal tract due to the use of NSAIDs, peptic ulcer and duodenal ulcer in the acute stage or active gastrointestinal bleeding (including a history).
• Hereditary intolerance to lactose or galactose (for example, congenital lactase deficiency or glucose-galactose malabsorption).
• Clinically significant pathologies of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys and blood.
• Other diseases that, in the opinion of the researcher, may affect the absorption, distribution, metabolism or excretion of both drugs, or increase the risk of negative consequences for the volunteer.
• The presence of mental disorders, including a history.
• Surgical interventions on the gastrointestinal tract, with the exception of appendectomy.

Sponsors & Collaborators

• Pharmtechnology LLC: lead
• ClinPharmInvest, LLC: collaborator

Study Sites (1)

Private healthcare institution "Clinical Hospital "RZD-Medicine" of the city of Yaroslavl"

Yaroslavl, 150047, Russia

Location

Study Officials

• Alexander Khokhlov

  ClinPharmInvest, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronika Kumpel

CONTACT

80173094418; specialist.fs@ft.by

Andrei Yaremchuk

CONTACT

development@ft.by

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2021
• Study Start: April 10, 2021
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-03

Locations

RU (1)