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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
TCTR20161102001 |
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Date of registration:
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02/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Bioequivalence Study of Etoricoxib Tablets under Fasting Condition
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Scientific title:
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A Bioequivalence Study of 120-mg Etoricoxib Tablets in Healthy Thai Volunteers under Fasting Condition |
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Date of first enrolment:
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09/01/2017 |
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Target sample size:
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Recruitment status: |
Pending (Not yet recruiting) |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20161102001 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Assoc. Prof. Noppamas
Rojanasthien |
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Address:
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Department of Pharmacology, Faculty of Medicine, Chiang Mai University
50200
Chiang Mai
Thailand |
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Telephone:
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+6653935359 |
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Email:
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nrojanas@med.cmu.ac.th |
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Affiliation:
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Department of Pharmacology, Faculty of Medicine, Chiang Mai University |
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Name:
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Assoc. Prof. Noppamas
Rojanasthien |
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Address:
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Mueng
50200
Chiang Mai
Thailand |
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Telephone:
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+6653935359 |
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Email:
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nrojanas@med.cmu.ac.th |
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Affiliation:
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Department of Pharmacology, Faculty of Medicine, Chiang Mai University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Must be in good health as determined by medical history, vital signs, and physical examination
Exclusion criteria: known kypersensitivity to etoricoxib and its components
history of renal and hepatic insufficiency, epigastric pain and GERD, illness, drug abuse, alcohol abuse.
Pregnant
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteer
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Primary Outcome(s)
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Bioequivalence Predose, 0.167,0.333,0.500,0.750,1,1.333,1.667,2,2.5,3,4,5,6,8,12,24,48,72,96 hr post doses PK measurement
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Secondary Outcome(s)
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Tmax, T1/2 and Ke 0.0 hour) and at 0.5, 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 7 Drug concentration in Plasma
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Source(s) of Monetary Support
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Medica Innova Co., Ltd.
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
Research Ethics Committee 2, Faculty of Medicine, Chiang Mai University
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Results
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Results available:
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Date Posted:
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Date Completed:
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28/02/2017 |
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URL:
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