Healthy volunteers
Conditions
Interventions
A single dose of 200 mg celecoxib capsule (Celebrexâ„¢) will be administered with 250 ml of drinking water. ,A single dose of 200 mg celecoxib test product will be administered with 250 ml of drinking
Active Comparator Drug,Active Comparator Drug
Celebrexâ„¢,Celecoxib test product
Sponsors
Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University
Pharmacy Service Center,
Faculty of Pharmacy,
Chiang Mai University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Male and female subjects age between 18-45 years (using the age at one’s last birthday on the date of informed consent). 2) Body Mass Index (BMI) between 18.5-25.0 kg/m2 (after decimal rounding) and body weight not less than 45 kg. 3) Healthy subjects based on medical history and physical examination. 4) Normal or not clinically significant abnormal of clinical laboratory results including blood urea nitrogen (BUN), serum creatinine (SCr), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, total protein, fasting blood glucose, serum potassium, complete blood count, and urinalysis. 5) Clinical laboratory result of hepatitis B is negative. 6) No clinically significant findings in vital sign measurement. 7) Nonsmoker or stop smoking for at least 6 months. 8) Females who participate in this study are: 8.1) Nonpregnant female (negative result for pregnancy test) 8.2) With childbearing potential, whom must commit to using acceptable non-hormonal contraceptive method of birth control for at least 2 weeks before and during the study and 2 weeks after drug administration in period 2 as judged by the clinical investigators, such as condoms, non-hormonal intrauterine device (IUD), or willing to remain abstinence (not engage in sexual intercourse). 8.3) Not currently breast feeding. 9) Subjects are able, willing, and likely to comply with study procedures and restrictions.
Exclusion criteria
Exclusion criteria: 1) Subjects with a history of allergy to celecoxib or related structure of celecoxib or other components in the formulation 2) Subjects who demonstrated allergic-type reaction of sulfonamides and NSAIDs 3) Subjects with currently or history of alcohol addiction or drug abuse 4) Subjects with currently or history of severe asthma, lung disease, seizures, gastrointestinal bleeding or ulcer, hepatic disease, renal disease, endocrine disease, cardiovascular disease or any other conditions that may affect bioavailability of the medication or safety of the subjects 5) Subject who has hyperkalemia. 6) Subjects who use of any medication (especially the drug which inhibited CYP2C9), including vitamins, herbal products, and dietary supplement, within 14 days before and during the study 7) Subjects who are unable to refrain from consumption of orange, pomelo and grapefruit within 7 days before and during the study 8) Subjects who are unable to refrain from caffeine-containing beverages and foods such as tea, coffee, cocoa, cola, chocolate or energy drink for 3 days before and during the study 9) Subjects with positive urine drug abuse test (methamphetamine, cannabinoid and opiates) 10) Subjects with positive alcohol breath test 11) Subjects with a history of blood donation greater than 300 ml or significant blood loss within 90 days before the initiation of the study 12) Subjects who participate in other clinical trials within 90 days before the initiation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Celecoxib concentration in plasma 0.0 - 48.0 h AUC0-t, AUC0-inf, and Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| safety at the beginning and at the end of the trial. clinical and laboratory examinations | — |
Countries
Thailand
Contacts
Public ContactNarawadee Niamhun
Pharmacy Service Center
Outcome results
None listed