Etoricoxib could commonly cause edema, dizziness, headache, palpitations, arrhythmia, hypertension, bronchospasm, constipation, heartburn and gastritis. Bioequivalence study
Conditions
Interventions
120mg, Film-coated, Oral solid dosage form,120mg, Film-coated, Oral solid dosage form
Active Comparator Drug,Experimental Drug
Arcoxia Tablet 120mg,Etoricoxib Tablet 120mg
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Human subjects aged from 18 to 45 years inclusive, 2.BMI range from 18.5 to 30.0 kg/m2 inclusive with the body weight Not Less Than 45 kgs, 3.Subjects who have Hemoglobin value Not Less Than 12.5 g/dL, 4.Normal vital signs (blood pressure, pulse rate and body temperature), 5.Normal medical and surgical history as approved by the physician or principal investigator prior to start of the study, 6.Normal functioning cardiovascular, respiratory, gastrointestinal, nervous system,musculoskeletal, vascular, genitourinary, endocrine/metabolic systems, 7.No history of dehydration from diarrhoea, vomiting, excess sweating or any other reason within a period of 24.00 hours prior to study check-in, 8.History of non-smoking, 9.Normal nail buds without clubbing, 10.Subjects with normal laboratory investigations (if any subject is enrolled into the study despite having a measurement outside the normal laboratory range, the physician should have a clearly documented and medically rigorous justification for making that exception), 11.Normal 12-lead electrocardiogram (ECG), 12.Normal chest X-Ray (P/A view).
Exclusion criteria
Exclusion criteria: 1.Contraindications or hypersensitivity to Etoricoxib and any of its excipients, 2.History or presence of any disease in the recent past (gastric, renal, respiratory, cardiac,neurological etc.) regarded by the physician as clinically important, 3.History or presence of significant alcoholism or drug abuse in the past year, 4.History or presence of significant asthma, urticaria or other allergic reactions, 5.History or presence of Active peptic ulceration or active gastro-intestinal (GI) bleeding, 6.History of usage of acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors in recent past, 7.History or presence of bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema,urticaria, or allergic-type reactions, 8.History or presence of inflammatory bowel disease, congestive heart failure, Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease, 9.History of difficulty in donating blood or difficulty in accessing veins, 10.Difficulty in swallowing Investigational products, 11.Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg during Period-01 check-in, 12.Diastolic blood pressure less than 70 mm Hg or more than 89 mm Hg during Period-01 check-in, 13.Pulse rate less than 60/minute or more than 100/minute during Period-01 check-in, 14.Use of any prescribed medication during last two weeks or OTC medicines or herbal medicinal products during the last one week preceding the first period check-in until completion of the study, 15.Major illness during 3 months before screening, 16.Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during the four weeks before screening, 17.Participation in a drug research study within past 3 months, 18.Donation of blood in the past 3 months before screening, 19.Refusal to abstain from water for at least 01.00 hour prior to dosing and for at least 01.00 hour post-dose, 20.Refusal to abstain from food for at least 10.00 hours before scheduled time for dosing and for at least 04.00 hours post-dose, 21.Refusal to abstain from alcohol or methylxanthine-containing beverages or foods (coffee,tea, carbonated drinks, chocolate) and grapefruit or its juice from 48.00 hours prior to the first period check-in until last sample collection, 22.Presence of disease markers hepatitis B & C virus and VDRL, 23.HIV positive, 24.Positive alcohol breath test at the time of check-in, 25.Positive urine test of drugs of abuse made at check-in, 26.Evidence of an uncooperative attitude
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics study Pre-dose, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00, 48.00 and 72.00 hours post dose. Each sample will be analysed using Liquid Chromatography with tandem mass spectrometry (LCMS/MS) to test the Etoricoxib analyte concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Bioequivalence Pre-dose, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00, 48.00 and 72.00 hours post dose. The Area Under the Curve (AUC) & Maximum concentration (CMAX) percentage will be calculated. The passing range is between 80 - 125% | — |
Countries
India
Contacts
Public ContactChuei Wuei Leong
Duopharma Innovation consultant
Outcome results
None listed