Healthy
Conditions
Interventions
coated tablets,Arava(R)
Experimental Drug,Active Comparator Drug
Sponsors
IBS
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Healthy Thai male subjects between the ages of 18 to 55 years. 2.Body mass index between 18.0 to 30.0 kg/mL 3.Non-smoker and/or non-consum er of nicotine containing produ Non-smoker means any subject who has never smoked or st days whereas non-consumer means any subject who stopped product consumption for at least 90 days. cts. opped for at least 90 nicotine containing 4.Normal laboratory values, including vital signs and physical examination , for all parameters in clinical laboratory tests at screening. Any abnormalities from the nonnal 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. 5.Male subject s who are not wishing to be a father of a child during the study or who are willing or able to use effective contraceptive e.g. condom or abstinence after admission until at least 30 days after investigational product administration. 6.Have voluntarily given written infonned 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 leflunomide (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme), teriflunomide or any of the excipients in the tablet 2.History of allergic reaction or hypersensiti vity to cholestyramine 3.History or evidence of clinically significant renal, hepatic (e.g. jaundice), gastrointestinal (e.g. colitis), hematological (e.g. anemia), endocrine (e.g. thyro id, diabetes) , pulmonary (e.g. interstiti al pneumonitis, pulmonar y fibrosis, tuberculosis) or respiratory (e.g. asthma), cardiovascu lar, psychiatric, neurologic (e.g. epilepsy), joint and bone (e.g. rheumatoid arthritis) or allergic disease (including drug allergies, but excluding untreated , asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 4.Ilistory or evidence of easy bruising or bleeding , recurrent infections, fever, paleness or unusual tiredness 5.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 6.History of problem s with swallowing tablet or capsule 7.History of sensitivity to heparin or heparin-induced thrombocytopenia 8.Any condition possibly affecting drug absorption e.g. oral mucous membrane lesions, gastrectomy , enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 9.History of dehydration from diarrhea, vomiting, excess sweating or any other reason within 24 hours prior to admission or prior to dosing 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, 2: 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 rnrnHg or more than 139 rnrnHg and diastolic blood pressure of less than 60 mmHg or more than 89 rnmHg 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.Investigation with blood sample shows albumin level less than 3.5 g/dl or more than 5.2 g/dl at screening 16.Investigation with blood sample shows total protein level less than 6.4 g/dl or more than 8.3 g/dl at screening 17.History or evidence of alcoho lism 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 spitits, such as rum, whisky, brandy etc.) 18.History or evidence of alco
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary PK parameter 0-72 Cmax, AUC0-72 | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary PK parameter 0-72 Tmax,t1/2,secondary PK parameter 0-72 Tmax,t1/2 | — |
Countries
thailand
Contacts
Public ContactUthai Suwannakood
IBS
Outcome results
None listed