Bioequivalence study Bioequivalence Etoricoxib
Conditions
Interventions
A randomized,
open-
labeled,
single-
dose,
two-
way crossover design with two-
period,
treatment,
Sponsors
Bio-innova and Synchron.Co.,Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Willingness to provide written informed consent prior to participate in the study. 2. Healthy Thai subjects are between 18 to 55 years of age. 3. The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2 with weight more than 45 kg. 4. Ability to comprehend the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects’ safety after the completion of the study. 5. Negative urine pregnancy test for women and no breast-feeding. 6. No history of usually smoking (more than 10 cigarettes per day). 7. No history of alcoholism (more than 2 years). 8. Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician. 9. For Male Subjects: Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study until 30 days after the after the last dose of the study medication as judged by the investigator(s), such as Condom, Condom with diaphragm, or abstinence. Subjects should also not donate sperm during the study conduct. 10. For Female Subjects: i) Female of child bearing potential practicing an acceptable method of birth control for at least 14 days prior to the first dose of study medication until 30 days after the after the last dose of the study medication as judged by the investigator(s), such as intrauterine device (IUD), abstinence or double barrier contraception, i.e., condom + diaphragm, condom or foam. ii) Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above, iii) Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
Exclusion criteria
Exclusion criteria: 1. History or evidence of allergy or hypersensitivity to Etoricoxib or any related drugs or any of the excipients of this product. 2. Subject with B.P. is Systolic B.P 100 beats per minute. 3. Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).* 4. Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).* 5. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).* 6. Positive results for HIV, hepatitis B or C virus tests. 7. Have more than one abnormal EKG, which is considered as clinically significant. * 8. History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, vascular disease (ischemic heart disease, peripheral arterial disease, cerebrovascular disease), glaucoma. 9. History or evidence of active peptic ulceration or gastrointestinal (GI) bleeding within the past 1 month before screening. 10. History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy. 11. Any major illness in the past 3 months or any significant ongoing chronic medical illness. 12. History of psychiatric disorder. 13. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study. 14. History of usually smoking (more than 10 cigarettes per day), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of each period of the study. 15. High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study. 16. Positive urine screening for drugs of abuse (Benzodiazepines, Marijuana (THC), Amphetamine, Cocaine and Opioids). 17. Receipt of any prescribed medicine within 14 days, or over-the-counter (OTC) drugs or herbal medicines/food within 7 days supplement or hormonal methods of contraception within 30 days (Depo-Provera® must be discontinued at least 6 months) prior to receiving the first dose of study medication. 18. History of difficulty in accessibility of veins in left and right arm. 19. Blood donation (one unit or 450 mL) within the past 3 months before the study. 20. Participation in any clinical study within the past 3 months before the study. 21. Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol. 22. Consumption of food or beverages containing grapefruit, seville oranges and/or pomelo for 7 days prior to the first dosing and until completion of the study. (* Depend on decision of principal investigator and/or clinical investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t and AUC0-inf 0,0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 7, 9, 12, 24, 48,72 and 96 hours Pharmacokinetic parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety 1.0, 2.0, 3.0, 5.0, 7.0, 9.0, 12.0, 24.0, 48.0, 72.0 and 96.0 hours Safety monitoring | — |
Countries
ไทย
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova and Synchron.Co.,Ltd
Outcome results
None listed