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Completed

NCT Number: NCT05532280

Bioequivalence Study of Etoricoxib in Healthy Adult Subjects Under Fasting Condition

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Future Research Center (FRC)

Cairo, 11835, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Etoricoxib 90 mg film coated tablet

Drug

an immediate-release tablet containing 90 mg of Etoricoxib

Other names: Test product (T)

Arcoxia 90 mg film coated tablet

Drug

an immediate-release tablet containing 90 mg of Etoricoxib

Other names: Reference product (R)

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

    Time until Cmax is reached

  2. 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

    the time required for the Etoricoxib plasma concentration to decrease by 50% after the pseudo-equilibrium of distribution has been reached

  3. 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

    First-order rate constant associated with the terminal (log-linear) portion of the curve

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 8, 2022
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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