Healthy Thai Volunteers Healthy Thai Volunteers
Conditions
Interventions
1.A Single Dose, Randomized, Open-label, One-period Parallel Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets in Healthy Thai Male Volunteers under Fasting Conditions 2.Blood sam
Experimental Drug,Active Comparator Drug
Leflunomide 20 mg Film-coated Tablets,ARAVA 20 MG TABLET
Sponsors
International Bio Service
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 18.5 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.Male subjects 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 check-in until 30 days after investigational product administration. 5.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 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 hypersensitivity to cholestyramine 3.History or evidence of clinically significant renal, hepatic, gastrointestinal (e.g. colitis), hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes mellitus), pulmonary or respiratory (e.g. asthma, COPD), cardiovascular (e.g. hyper-/hypotension), psychiatric, neurologic (e.g. convulsant, peripheral neuropathy), 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 easy bruising or bleeding, recurrent infections, fever, paleness or unusual tiredness 5.History or evidence of significantly impaired bone marrow function, significant anaemia, leucopenia or thrombocytopenia 6.History or evidence of severe hypoproteinaemia or nephrotic syndrome 7.History or evidence of severe immunodeficiency states 8.Investigation with blood sample shows albumin level less than 3.5 g/dl or more than 5.2 g/dl at screening 9.Investigation with blood sample shows total protein level less than 6.6 g/dl or more than 8.7 g/dl at screening 10.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 11.History of problems with swallowing tablet or capsule. 12.History of sensitivity to heparin or heparin-induced thrombocytopenia. 13.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy. 14.History of vomiting or diarrhea within 24 hours prior to check-in. 15.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine). 16.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 check-in day. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 mins each. The last measurement value should be used to determine the subject eligibility. 17.12-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 eligibility. 18.Investigation with blood sample shows positive test for HBsAg. 19.Abnormal liver function, >1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test. 20.Have eGFR (CKD-EPI) < 90 mL/min/1.73 m2 based on serum creatinine results, at the screening laboratory test or during enrollment. 21.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in and continued for entire duration of the study. 22.History or evidence of alcoholism or harmful use of alcohol within 2 years prior to screening i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard dr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in plasma 0-72 hr Pharmacokinetic evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| N/A N/A N/A | — |
Countries
Thailand
Contacts
Public ContactPorranee Puranajoti
International Bio Service
Outcome results
None listed