A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Finasteride 1 mg Film-coated Tablets (FINASTERIDE, BANGKOK LAB & COSMETIC CO.,LTD.,Thailand) and Reference Product (PROPECIA, MSD International GmBH (Puerto Rico Branch) LLC, U.S.A.) in Healthy Thai Male Volunteers under Fasting Conditions
- Conditions
- FastingBioequivalence study,healthy,Thai male volunteers,
- Registration Number
- TCTR20170712003
- Lead Sponsor
- International Bio Service Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 26
1 Healthy Thai male subjects between the ages of 18 to 55 years
2 Body mass index between 18 to 25 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 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 finasteride or related structure (e.g. testosterone) to any of the components of the product
2 History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine e.g. thyroid, pulmonary, cardiovascular, phychiatric, 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 reproductive system disorders e.g. erectile dysfunction or ejaculation disorders
4 History or evidence of phychiatric disorder e.g. anxiety, depression occurring within the 2 years prior to admission that required hospitalization or medication
5 History or evidence of galactose intolerance the Lapp lactase deficiency or glucose galactose malabsorption
6 History of problems with swallowing tablets
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 preceding diarrhea within 24 hours prior to admission 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 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
12 Investigation with blood sample shows positive test for HBsAg
13 Abnormal liver function >=1.5 times of upper normal limit of reference range for ALT AST or bilirubin levels at screening laboratory test
14 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
15 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
16 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
17 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
18 Use of prescription or nonprescription drugs (e.g. minoxidil, paracetamol, antacid, ibuprofen, erythromycin, ketoconazole etc.), herbal medications or supplements (e.g. St.John's wort), vitamins, or iron or dietary supplements within 14 days prior to admission in Period 1 or during enrollment
19 Participated in other clinical trials within 90 days or ongoing long-term clinical trial prior to admission in Period 1 (except for the subjects who dropout/withdrawn from the previous study prior to Period 1 dosing) or during enrollment
20 Blood donation or blood loss >= 1 unit (1 unit is equal t
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Finasteride plasma concentration 0-36 hr Cmax, AUC0-tlast and AUC0-infinity
- Secondary Outcome Measures
Name Time Method Finasteride plasma concentration 0-36 hr Tmax, t1/2, lamda Z, AUC0-tlast / AUC0-infinity, AUC%extraporate and MRT