Bioequivalence Study Healthy Thai Volunteers Leflunomide 20 mg Film-coated Tablets Bioequivalence Study Healthy Thai Volunteers
Conditions
Interventions
Generic leflunomide 20 mg film-coated tablet, Lefos,
manufactured by Pharmathen International S.A.Each tablet
contains 20 mg leflunomide,Test (T): Generic leflunomide 20 mg film-coated tablet, Lefos,
Active Comparator Drug,Active Comparator Drug
Test (T): Generic leflunomide 20 mg film-coated tablet,Reference (R): Leflunomide 20 mg film-coated tablet, Arava
Sponsors
International Bio Service Co.,Ltd.
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/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 at least 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, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric, neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 4.Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19 5.History or evidence of easy bruising or bleeding, recurrent infections, fever, paleness or unusual tiredness 6.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 7.History of problems with swallowing tablet or capsule 8.History or evidence of impairment of liver function 9.History or evidence of moderate to severe renal insufficiency 10.History or evidence of severe hypoproteinaemia or nephrotic syndrome 11.Investigation with blood sample shows albumin level less than 3.5 g/dl or more than 5.2 g/dl at screening 12.Investigation with blood sample shows total protein level less than 6.6 g/dl or more than 8.7 g/dl at screening 13.History or evidence of severe immunodeficiency states 14.History or evidence of significantly impaired bone marrow function, significant anaemia, leucopenia or thrombocytopenia 15.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. 16.History or evidence of colitis 17.History or evidence of peripheral neuropathy 18.History of sensitivity to heparin or heparin-induced thrombocytopenia 19.Any condition possibly affecting drug absorption e.g. oral mucous membrane lesions, gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 20.History of dehydration from diarrhea, vomiting, excess sweating or any other reason within 24 hours prior to check-in or prior to dosing 21.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 22.12-lead ECG demonstrating QTc >450 , a QRS interval >120 or with an abnormality considered clinically significant at screening. If QTc exceeds 450 , or QRS exceeds 120 , 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. 23.Investigation with blood sample shows positive test for HBsAg 24.Abnormal liver function, more than 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 25.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 contin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Leflunomide metabolite, teriflunomide or A771726, plasma concentration 0-72 hrs, 17 points between 0-24 hrs, 2 ambulatory visits Cmax and Truncated AUC0-72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Leflunomide metabolite, teriflunomide or A771726, plasma concentration 0-72 hrs, 17 points between 0-24 hrs, 2 ambulatory visits Tmax , t1/2 will be determined from the plasma concentration data of analytes. | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed