Open Label, Randomized, Two-way Crossover, Two-sequence, Two-period, Two-treatment Bioequivalence Study of Celecoxib Capsules 200 mg Preparations in Healthy Thai Volunteers
- Conditions
- Male and female,healthy volunteers,aged 18ᇋ,body mass index between 18.0 to 25.0 kg/m2.Celecoxib,Bioequivalence study,Thai,Healthy
- Registration Number
- TCTR20170104001
- Lead Sponsor
- International Bio Service Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
1Healthy Thai male/female subjects between the ages of 18 to 55 years.
2Body mass index between 18.0 to 25.0 kg/m2.
3Normal 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.
4Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
5Female 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
6Male 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.
7Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
1History 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
2History or evidence of cardiovascular bleeding, active gastrointestinal bleeding, active gastric or duodenal or peptic ulcer
3History 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
4History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
5History of problems with swallowing capsule
6History of sensitivity to heparin or heparin-induced thrombocytopenia
7Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
8History of preceding diarrhea within 24 hours prior to admission in each period
9History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
1012-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.
11Investigation with blood sample shows positive test for anti-HIV, anti-HCV, VDRL or HBsAg
12Abnormal liver function,  1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
13Have 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.
14Investigation with blood sample shows level of sodium less than 135 mmol/l or more than 145 mmol/l at screening laboratory test
15Investigation with blood sample shows level of potassium less than 3.5 mmol/l or more than 5.1 mmol/l at screening laboratory test
16Have renal creatinine clearance (CrCl) < 30 mL/min based on serum creatinine results at the screening laboratory test
17History 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
18History 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
19History or evidence of habitual cons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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