Bioequivalence Study Healthy Thai Volunteers Etoricoxib 120 mg Film-coated Tablet
Conditions
Interventions
Generic etoricoxib 120 mg film-coated tablet , Each tablet contains etoricoxib 120 mg.
,Etoricoxib 120 mg film-coated tablet, ARCOXIA Reg. No. of Vietnam: VN-20808-17, manufactured by ROVI PHARMA INDU
Experimental Drug,Active Comparator Drug
Generic etoricoxib 120 mg film-coated tablet,Etoricoxib 120 mg film-coated tablet, ARCOXIA
Sponsors
International Bio Service Co.,Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Healthy Thai male or female subjects between the ages of 18 to 55 years 2.Body mass index between 18.0 to 30.0 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 check-in in Period 1. Injectable contraceptives e.g. Depo-Provera will be discontinued at least 6 months prior to check-in 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 check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1: Postmenopausal for at least 1 year or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months 6.Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2. 7.Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study
Exclusion criteria
Exclusion criteria: 1.History of allergic reaction or hypersensitivity to etoricoxib or to any of the excipients of the product 2.History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper-/hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric, neurologic ( convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3.Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19 4.History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period 5.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 6.History of problems with swallowing tablet or capsule 7.History of sensitivity to heparin or heparin-induced thrombocytopenia 8.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 9.History of diarrhea or vomiting within 24 hours prior to check-in in each period 10.History or evidence of active peptic ulceration, gastrointestinal (GI) bleeding or inflammatory bowel disease 11.History or evidence of asthma, bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or other allergic reactions after taking aspirin or other NSAIDs 12.History or evidence of congestive heart failure, ischemic heart disease, peripheral arterial disease or cerebrovascular disease (including persons who have recently undergone coronary artery bypass graft surgery or angioplasty) 13Have 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 check-in day. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 15 minutes each. The last measurement value should be used to determine the subject eligibility. 14.Have renal creatinine clearance (CrCl) < 30 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockcroft-Gault formula), at the screening laboratory test 15.History or evidence of severe hepatic impairment 16.12-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 eligibility. 17Investigation with blood sample shows positive test for HBsAg. 18Abnormal liver function, more than 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Etoricoxib concentrations 0-72 hrs Cmax and Truncated AUC0-72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Etoricoxib concentration 0-72 hrs Tmax, t1/2 | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co.,Ltd
Outcome results
None listed