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A Bioequivalence Study of Etoricoxib Tablets under Fasting Condition

A Bioequivalence Study of 120-mg Etoricoxib Tablets in Healthy Thai Volunteers under Fasting Condition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20161102001
Enrollment
Unknown
Registered
2016-11-02
Start date
2017-01-09
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Interventions

None listed

Sponsors

Ranbaxy (Thailand) Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Must be in good health as determined by medical history, vital signs, and physical examination

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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—

Secondary

MeasureTime frame
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—

Countries

Thailand

Contacts

Public ContactAssoc. Prof. Noppamas Rojanasthien

Department of Pharmacology, Faculty of Medicine, Chiang Mai University

nrojanas@med.cmu.ac.th+6653935359

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026