Healthy Volunteers Bioequivalence study Dutasteride
Conditions
Interventions
Reference Product of Dutasteride 0.5 mg,Test Product of Dutasteride 0.5 mg
Experimental Drug,Experimental Drug
Dutasteride ,Dutasteride
Sponsors
Intega (Thailand) 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 25.0 kg/m2. 3.Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. 4.Subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 7 days after the end of study. 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 5ï¡-reductase inhibitors or any of the components of the product 2.History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine e.g. thyroid, pulmonary, cardiovascular e.g. cardiac failure, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3.History or evidence of abnormal urinary flow and/or urological diseases including prostate cancer 4.History of problems with swallowing tablet or capsule 5.History of sensitivity to heparin or heparin-induced thrombocytopenia 6.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 7.History of preceding diarrhea within 24 hours prior to admission in each period 8.History or evidence of drug addict or investigation with urine sample shows a positivetest for drug of abuse (morphine, marijuana or methamphetamine) 9.12-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 should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject’s eligibility. 10.Investigation with blood sample shows positive test for HBsAg. 11.Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 12.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 13.History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 14.History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 15.Consumption or drinking of grapefruit juice or orange or its supplement/containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 16.Use of prescription or nonprescription drugs (e.g. paracetamol, erythromycin, ketoconazole, verapamil, diltiazem etc.), herbal medications or supplements (e.g. St. John’s wort, milk thistle), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to admission in Period 1 or during enrollment 17.Participated in other clinical trial within 90 days or ongoing long-term clinical trial prior to admission in Period 1 (except for the subjects who dropped out/withdrawn from the previous study prior to Period 1 dosing) or during enrollment 18.Blood donation or blood loss ≥1 unit (1 unit is equal to 350-450 mL of blood) within 90 days prior to admission in Period 1 or during enrollment 19.Subjects with poor venous access or intolerant to venepuncture 20.Unwillin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dutasteride level in plasma 0.00,0.25,0.50,0.75,1.00,1.50,2.00,2.50,3.00,3.50,4.00,6.00,8.00,10.00,12.00,24.00,36.00,48.00,72.00 ng/mL | — |
Secondary
| Measure | Time frame |
|---|---|
| Body temperature 0,3.00,7.00,12.00,24.00,36.00,48.00,72.00hr Celsius,Blood pressure 0,3.00,7.00,12.00,24.00,36.00,48.00,72.00hr mmHg,Pulse rate 0,3.00,7.00,12.00,24.00,36.00,48.00,72.00hr BPM,Respiratory rate 0,3.00,7.00,12.00,24.00,36.00,48.00,72.00hr BPM,Adverse Event 0.00,0.25,0.50,0.75,1.00,1.50,2.00,2.50,3.00,3.50,4.00,6.00,8.00,10.00,12.00,24.00,36.00,48.00,72.00 Asking the question and spontaneous reporting,Physical Examination 72.00hr Examined by physician,Electrocardiogram 72.00hr 12-Lead ECG,Clinical Laboratory Examination (Blood Chemistry and Hematology) 72.00hr Level in Blood | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed