Male and female,
Conditions
Interventions
,Reference (R): Celecoxib 200 mg capsule,
CELEBREXâ„¢,
Reg. No. 1C 172/49 (N),
containing 200 mg celecoxib per capsule,
manufactured by Neolpharma,
Caguas,
Puerto Rico and imported by Pfizer (Thailand) Limited,
Bangkok,
Thailand.
Test (T): Celecoxib 200 mg capsule,
Celecoxib Capsules 200 mg,
Goa 403722,
,Celecoxib 200 mg capsule
Sponsors
International Bio Service Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1 Healthy Thai male/female subjects between the ages of 18 to 55 years. 2 Body mass index between 18.0 to 25.0 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. 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. 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 celecoxib, sulfonamide, acetylsalicylic acid (aspirin) or other NSAIDs including other cyclooxygenase-2 specific inhibitors or any other ingredient of the product 2 History or evidence of cardiovascular bleeding, active gastrointestinal bleeding, active gastric or duodenal or peptic ulcer 3 History or evidence of clinically significant renal, hepatic e.g. jaundice, gastrointestinal e.g. Inflammatory bowel disease, hematological, endocrine e.g. thyroid, pulmonary or respiratory e.g. asthma, cardiovascular e.g. heart failure, cardiovascular thrombotic events, myocardial infarction, stroke etc., psychiatric, neurologic e.g. depression, insomnia or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 4 History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 5 History of problems with swallowing capsule 6 History of sensitivity to heparin or heparin-induced thrombocytopenia 7 Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 8 History of preceding diarrhea within 24 hours prior to admission in each period 9 History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 10 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. 11 Investigation with blood sample shows positive test for anti-HIV, anti-HCV, VDRL or HBsAg 12 Abnormal liver function,  1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 13 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. 14 Investigation with blood sample shows level of sodium less than 135 mmol/l or more than 145 mmol/l at screening laboratory test 15 Investigation with blood sample shows level of potassium less than 3.5 mmol/l or more than 5.1 mmol/l at screening laboratory test 16 Have renal creatinine clearance (CrCl) < 30 mL/min based on serum creatinine results at the screening laboratory test 17 History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in Period 2 18 History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admission in Period 1 and continued until last sample collection in Period 2 19 History or evidence of habitual cons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Celecoxib plasma concentration 0,0.5,1,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.5,5,6,8,12,18,24,36,48,72 hr post-dose Cmax, AUC0-tlast and AUC0-∞ | — |
Secondary
| Measure | Time frame |
|---|---|
| Celecoxib plasma concentration 0,0.5,1,1.5,1.75,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.5,5,6,8,12,18,24,36,48,72 hr post-dose Tmax, t1/2, λz, AUC0-tlast/AUC0-∞, AUC%extrapolate, MRT | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co. Ltd.
Outcome results
None listed