A Bioequivalence Study of Etoricoxib Tablets under Fasting Conditio
Not Applicable
Not yet recruiting
- Conditions
- Healthy Volunteer
- Registration Number
- TCTR20161102001
- Lead Sponsor
- Ranbaxy (Thailand) Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 32
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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