A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Celecoxib 200 mg Capsules and Reference Product (CELEBREXâ„¢) in Healthy Thai Volunteers under Fasting Conditions
- Conditions
- Healthy Thai Volunteers
- Registration Number
- TCTR20200423003
- Lead Sponsor
- International Bio Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 40
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 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 in Period 2. 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
6. Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission 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.
1. History of allergic reaction or hypersensitivity to celecoxib, sulfonamide, acetylsalicylic acid (aspirin), other NSAIDs including other cyclooxygenase-2 specific inhibitors or any other ingredient of the product
2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. thyroid diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypertension), psychiatric, neurologic (e.g. seizures), 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 cerebrovascular disease, myocardial infraction, congestive heart failure, coronary heart disease (stenosed or occluded) or paresis due to cerebrovascular accident
4. History or evidence of cardiovascular bleeding, gastrointestinal bleeding, gastric or duodenal or peptic ulcer
5. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
6. History of sensitivity to heparin or heparin-induced thrombocytopenia
7. History of problems with swallowing tablet or capsule
8. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
9. History of preceding diarrhea or dehydration within 24 hours prior to admission in each period
10. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
11. 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.
12. Investigation with blood sample shows positive test for HBsAg.
13. Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
14. Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day and the day of admission. If abnormal blood pressure detects, the measurement will be repeated two more times after take a rest for at least 5 minutes each. The last measurement value will be used to determine the subject’s eligibility.
15. History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to admission and continued for entire duration of the study
16. 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 or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.)
17. History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to admission and continued for entire duration of the study or alcohol breath test shows positive result
In case of alco
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug concentration in plasma 0-72 hr Pharmacokinetic evaluation
- Secondary Outcome Measures
Name Time Method Safety evaluation 0-72 hr Adverse events