A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Etoricoxib 120 mg Film-coated Tablets and Reference Product (ARCOXIA) in Healthy Thai Volunteers under Fasting Conditions
- Conditions
- the rate and extent of absorptionBioequivalence
- Registration Number
- TCTR20200428003
- Lead Sponsor
- PT Novell Pharmaceutical Laboratories
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 28
1. Body mass index between 18.0 - 30.0 kg/m^2.
2. Healthy Thai male or female subjects between the ages of 18 to 55 years.
3. Normal laboratory value, including vital sign and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal of 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 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 contraceptive 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 participant in this study.
1. History of allergic reaction or hypersensitivity to etoricoxib or any of the excipients of the products.
2. History or evidence of clinically significant renal, hepatic gastrointestinal, hematological (e.g. anemia), endocrine (e.g. thyroid), pulmonary or respiratory (e.g. asthma), 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 of 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, ischemic 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 lactose 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 affection drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy.
10. History of vomiting or diarrhea within 24 hours prior to check-in 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 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 5 minutes each. The last measurement value should be used to determine the subject's eligibility.
13. 12-lead ECG demonstrating Qtc is greater than 450 msec, a QRS interval is greater than 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 two times and the average of the three QTc or QRS values will be used to determine the subject's eligibility.
14. Investigation with the blood sample shows positive test for HBsAg.
15. Abnormal liver function, is greater than or equal to 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test.
16 Have renal creatinine less than 30 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockfrcoft-Gault formula), at the screening laboratory test.
17. History or evidence of habitual use of tobacco or nicotine-containing products and cannot abstain for at least 48 hours prior to check-in in Oeriod 1 and continued for entire duration of the study.
18. History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the rate and extent of absorption Day 4 of period 1 and period 2 % AUC
- Secondary Outcome Measures
Name Time Method /A N/A N/A