Bioequivalence Study of Etoricoxib in Healthy Adult Subjects Under Fasting Condition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-28

Study Completion Date

2021-01-14

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Etoricoxib 90 mg film coated tablet

Intervention Type DRUG

an immediate-release tablet containing 90 mg of Etoricoxib

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

Group Type ACTIVE_COMPARATOR

Arcoxia 90 mg film coated tablet

Intervention Type DRUG

an immediate-release tablet containing 90 mg of Etoricoxib

Interventions

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Etoricoxib 90 mg film coated tablet

an immediate-release tablet containing 90 mg of Etoricoxib

Intervention Type DRUG

Arcoxia 90 mg film coated tablet

an immediate-release tablet containing 90 mg of Etoricoxib

Intervention Type DRUG

Other Intervention Names

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Test product (T) Reference product (R)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes