Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»TCTR
Year
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2023
INTERVENTION: Experimental Drug,Active Comparator Drug he new generic products which were recently developed. Subjects must swallow a whole tablet, and not chew or crush the tablet. A single dose of Silodosin Tablets 4 mg will be given with water. Investigational product will be administered directly from the unit dose‐container into the open mouth of subjects. After the administration, the subjects oral cavity will be checked by using flashlight to confirm complete medication and fluid consumption by pharmacists.,The marketed original products which were already available in the market. Subjects must swallow a whole tablet, and not chew or crush the tablet. A single dose of Urief Tablets 4 mg will be given with water. Investigational product will be administered directly from the unit dose‐container into the open mouth of subjects. After the administration, the subjects oral cavity will be checked by using flashlight to confirm complete medication and fluid consumption by pharmacists. Silodosin Tablets 4 mg,Urief Tablets 4 mg CONDITION: Healthy subjects ; Silodosin Tablets 4 mg Bioequivalence Silodosin Tablets 4 mg Bioequivalence PRIMARY OUTCOME: Cmax, AUC0‐t and AUC0‐inf (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 7.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours Pharmacokinetic parameters SECONDARY OUTCOME: Safety; Adverse events 0.5, 1.0, 2.0, 3.0, 6.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours Safety monitoring, vital sign INCLUSION CRITERIA: 1. Willingness to provide written informed consent prior to participate in the study. 2. Healthy Thai male subjects are between 18 to 55 years of age. 3. The Body Mass Inde X(BMI) ranges from 18.5 to 30 kg/m2. 4. Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects 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: 3ed03c9133fe2e809c6ceb842278d33e2ef70080
First added on: Feb 20, 2024