Authors
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Bio-innova Co., Ltd. -More
Category
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Primary study
Registry of Trials»Thai Clinical Trials Registry
Year
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2026
INTERVENTION: Experimental Drug,Active Comparator Drug Finasteride Tablets 1 mg ,Propecia The new generic products which were recently developed. Volunteer will receive a single dose of Finasteride Tablets 1 mg with 250 mL of drinking water. ,The marketed original products which were already available in the market. Volunteer will receive a single dose of Propecia with 250 mL of drinking water. CONDITION: Bioequivalence Finasteride Tablets 1 mg Healthy volunteers ; Bioequivalence Finasteride Tablets 1 mg PRIMARY OUTCOME: Blood Finasteride level pre‐dose (0.00 hour) and at 0.33, 0.67, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 36.00 hours Maximum plasma concentration, area under the plasma concentration curve from dosing to last observed concentration at time t, area under the plasma concentration curve extrapolated to infinite time SECONDARY OUTCOME: Vital sign (Systolic BP, Diastolic BP, Pulse) at check‐in, pre‐dose, at approximately 1.0, 2.0, 4.0, 12.0, 24.0 and 36.0 hours post‐dose Automatic blood pressure INCLUSION CRITERIA: 1. Willingness to provide written informed consent prior to participate in the study. 2. Healthy Thai male participants are between 18 to 55 years of age. 3. The Body Mass Inde X(BMI) ranges from 18.5 to 30.0 kg/m2. 4. Comprehensive understanding of the nature and purpose of the study, compliance with the requirements of the entire protocol and agreement to allow investigators to collect approximately 10 mL of blood for screening and approximately 7 mL of blood for monitoring participants safety after the completion of the study. 5. Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.
Epistemonikos ID: 3eec6fa8d91b41be0640ac44593f0e9d25090d9a
First added on: Jul 21, 2026