Bioequivalence Study,
Conditions
Interventions
coated tablet,
Each tablet contains 120 mg of etoricoxib.,ARCOXIA®,
Reg.
No. 1C 118/55 (N),
Bangkok,
Thailand.
Each tablet contains 120 mg of etoricoxib.
Active Comparator Drug,Active Comparator Drug
coated Tablets (test Product),Etoricoxib 120 mg Film-
Sponsors
International Bio Service Co. Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1 Healthy Thai male/female subjects between the ages of 18 to 55 years. 2 Body mass index between 18.0 to 25.0 kg/m2. 3 Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study. 4 Non-pregnant woman (negative pregnancy test) and not currently breast feeding. 5 Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to admission in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to admission in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to admission in Period 1 until 7 days after the end of study. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to admission in Period 1: •Postmenopausal for at least 1 year or •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
Exclusion criteria
Exclusion criteria: 1 History of allergic reaction or hypersensitivity to etoricoxib or any of the excipients of the product 2 History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. thyroid), pulmonary or respiratory, cardiovascular, psychiatric, neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3 History or evidence of active peptic ulceration, gastrointestinal (GI) bleeding or inflammatory bowel disease 4 History or evidence of asthma, acute rhinitis, nasal polyps, angioneurotic oedema, asthma, urticaria, or other allergic reactions after taking aspirin or other NSAIDs 5 History or evidence of congestive heart failure, ischaemic heart disease, peripheral arterial disease or cerebrovascular disease (including persons who have recently undergone coronary artery bypass graft surgery or angioplasty) 6 History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption 7 History of problems with swallowing tablet or capsule 8 History of sensitivity to heparin or heparin-induced thrombocytopenia 9 Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 10 History of preceding diarrhea within 24 hours prior to admission in each period 11 History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 12 Have sitting systolic blood pressure less than 90 mmHg or more than 139 mmHg or diastolic blood pressure less than 60 mmHg or more than 89 mmHg at screening or on the day of admission. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 minutes each. The last measurement value should be used to determine the subject’s eligibility. 13 12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject’s eligibility. 14 Investigation with blood sample shows positive test for HBsAg. 15 Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 16 Have renal creatinine clearance (Clcr) < 30 mL/min based on serum creatinine results at the screening laboratory test Calculation for Creatinine Clearance Creatinine Clearance (mL/min)* = Clcr = 17 History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 18 History or evidence of alcoholism, regular alcohol consumption or alcohol containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 19 History or evidence of habitual consume of tea, coffee, xanthine or caffe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Etoricoxib plasma concentrations 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72 hours post-dose Cmax and Truncated AUC0-72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Etoricoxib plasma concentrations 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72 hours post-dose Tmax , t1/2 and lamda z | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd
Outcome results
None listed