Bioequivalence Study in Healthy Thai Male Volunteers Dutasteride 0.5 mg Soft Capsules in Healthy Thai Male Volunteers
Conditions
Interventions
Each capsule contains 0.5 mg dutasteride.,Each capsule for oral use contains 0.5 mg dutasteride, AVODART, Reg. No. 1C 74/56 (N), manufactured by GlaxoSmithKline Pharmaceuticals S.A., Poznan
Experimental Drug,Active Comparator Drug
Test (T): Generic dutasteride 0.5 mg soft capsule,Reference (R): Dutasteride 0.5 mg soft capsule, AVODART
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 14 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 dutasteride, other 5-reductase inhibitors or any of the components of the product 2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo-/hyperthyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypo-/hypertension), psychiatric, neurologic (e.g. seizures), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19 4. History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period 5. History or evidence of abnormal urinary flow and/or urological diseases including prostate cancer 6. History of problems with swallowing tablet or capsule 7. History of sensitivity to heparin or heparin-induced thrombocytopenia 8. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 9. History of diarrhea or vomiting within 24 hours prior to check-in in each period 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. Have pulse rate below 60 beats/minute or above 100 beats/minute 12. 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 or check-in day. 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 is eligibility. 13.12 lead ECG demonstrating QTc more than 450 msec, a QRS interval more than 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. 14.Investigation with blood sample shows positive test for HBsAg. 15.Abnormal liver function, more than or equal 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 16.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 17.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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dutasteride 0.5 mg soft capsule 0-72 hours Cmax and Truncated AUC 0-72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Dutasteride 0.5 mg soft capsule 0-72 hours Tmax, t1/2 and Lamda z | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed