Bioequivalence Study of Etoricoxib in Healthy Adult Subjects Under Fasting Condition

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Etoricoxib 90 mg film coated tablet; Drug: Arcoxia 90 mg film coated tablet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11835
    • Future Research Center (FRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Product (T); subjects were administered a single tablet of 90 mg Etoricoxib with approximately 240 ml water after an overnight fast of 10 hours	Drug: Etoricoxib 90 mg film coated tablet; an immediate-release tablet containing 90 mg of Etoricoxib; Other Names: Test product (T)
Active Comparator: Reference Product (R); subjects were administered a single tablet of 90 mg Etoricoxib with approximately 240 ml water after an overnight fast of 10 hours	Drug: Arcoxia 90 mg film coated tablet; an immediate-release tablet containing 90 mg of Etoricoxib; Other Names: Reference product (R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax)	Cmax is observed at the maximum of Etoricoxib peak concentration	(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 area under the curve (AUC 0-t)	Cumulative Area Under the Etoricoxib plasma concentration-time Curve calculated from 0 to time of last quantifiable concentration (t last) using the Trapezoidal method	(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 area under the curve extrapolated to infinity (AUC0-∞)	AUC from Dosing time extrapolated to infinity, based on the last observed concentration	(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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum time (Tmax)	Time until Cmax is reached	(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
Apparent terminal half-life (t½)	the time required for the Etoricoxib plasma concentration to decrease by 50% after the pseudo-equilibrium of distribution has been reached	(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
Apparent elimination rate constant (Kel).	First-order rate constant associated with the terminal (log-linear) portion of the curve	(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

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Actual): January 14, 2021
• Study Completion (Actual): January 14, 2021

Study Registration Dates

• First Submitted: September 4, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Bioequivalence; Crossover; Randomized; Etoricoxib
• 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: COX-B-20-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months following article publication and no end date
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to To gain access.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No