A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Dutasteride 0.5 mg Capsules (Dutride, Cyndea Pharma S.L., Spain) and Reference Product (AVODARTâ„¢, GlaxoSmithKline Pharmaceuticals S.A., Republic of Poland) in Healthy Thai Male Volunteers under Fasting Conditions
- Conditions
- Healthy Volunteer
- Registration Number
- TCTR20180302009
- Lead Sponsor
- Pharmaland(1982) Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- Male
- Target Recruitment
- 32
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
1 History of allergic reaction or hypersensitivity to dutasteride other 5 alpha 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(e.g. convulsion) 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 dehydration from diarrhea, vomiting, excess sweating or any other reasons within 24 hr prior to admission in each period
8 History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
9 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 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 more than or equal 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 more than or equal 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 venou
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dutasteride level in plasma 0.00,0.25,0.50,0.75,1.00,1.50,2.00,2.50,3.00,4.00,6.00,8.00,10.00,12.00,24.00,36.00,48.00,72.00 hr ng/ml
- Secondary Outcome Measures
Name Time Method Body temperature 0,7,7,12,24 hr Celsius,Blood pressure 0,7,7,12,24 hr mmHg,Pulse rate 0,7,7,12,24 hr BPM,Respiratory rate 0,7,7,12,24 hr BPM,Adverse event 0.00,0.25,0.50,0.75,1.00,1.50,2.00,2.50,3.00,4.00,6.00,8.00,10.00,12.00,24.00,36.00,48.00,72.00hr Asking question and spontaneous reporting,Physical examination 0.00 and 72.00 hr by physician,Clinical laboratory examination 72.00 hr Level in blood,Electrocardiogram 72.00 hr 12-Lead ECG