Healthy volunteers Bosentan, Bioequivalence Study, Healthy Thai Volunteer
Conditions
Interventions
Bosentan 125 mg film-
coated tablet (Reference product),Bosentan 125 mg film-
Experimental Drug,Experimental Drug
Bosentan 125 mg,Bosentan 125 mg
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 willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2. 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 bosentan or any of the excipients of the product 2.History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. thyroid), pulmonary (e.g. pulmonary hypertension, pulmonary oedema) or respiratory (e.g. asthma), cardiovascular (e.g. hypertension, hypotension, heart failure), psychiatric (e.g. depression), neurologic, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3.History of problems with swallowing tablet or capsule 4.History of sensitivity to heparin or heparin-induced thrombocytopenia 5.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 6.History of vomiting or diarrhea within 24 hours prior to check-in in each period 7.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 8.12-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 subjects eligibility. 9.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 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 subjects eligibility. 10.Investigation with blood sample shows positive test for HBsAg. 11.Investigation with blood sample shows abnormal liver function, out of normal limit of reference range for ALT, AST or bilirubin levels, at screening laboratory test 12.Investigation with blood sample shows abnormal haemoglobin concentration, higher or lower value than normal limit of reference range, at screening laboratory test 13.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study 14.History or evidence of alcoholism 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 spirits, such as rum, whisky, brandy etc.) 15.History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study or alcohol breath test shows positive result In case of alcohol breath test result represents the alcohol concentration range of 1 - 10 mg% BAC and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not more than 10 minutes. The result of the last time should be used for subjects eligibility which must be 0 mg%BAC. 16.History or evidence of habitual consume of tea, coff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bosentan plasma concentrations 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 24, 36 h Cmax, AUC0-tlast and AUC0-inf | — |
Secondary
| Measure | Time frame |
|---|---|
| Bosentan plasma concentrations 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 24, 36 h Tmax, t1/2, AUC0-tlast/AUC0-∞, AUC%extrapolate, λz and MRT | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed