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: Apixaban 5 mg tablets ,Eliquis 5 mg tablets Experimental Drug,Active Comparator Drug The new generic products which were recently developed. Volunteer will receive a single dose of Apixaban 5 mg tablets of either test or reference with 250 mL of drinking water,The marketed original products which were already available in the market. Volunteer will receive a single dose of Eliquis 5 mg tablets either test or reference with 250mL of drinking water. CONDITION: Bioequivalence Apixaban 5 mg tablets Healthy subjects ; Bioequivalence Apixaban 5 mg tablets PRIMARY OUTCOME: Cmax, AUC0‐t and AUC0‐inf 0.00, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00and 48.000 hours Pharmacokinetics parameter SECONDARY OUTCOME: Safety; Adverse events 2.0, 4.0, 6.0, 12.0, 24.0, 36.0 and 48.0 hours Safety monitoring INCLUSION CRITERIA: 1. Willingness to provide written informed consent prior to participate in the study. 2. Healthy Thai subjects are between 18 to 55 years of age. 3. The Body Mass Inde X(BMI) ranges from 18.5 to 30 kg/m. 4. Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 10 mL of blood for monitoring subjects safety after the completion of the study. 5. Negative urine pregnancy test for women and no breast‐feeding. 6. 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: 057d18c82c8787661abafa5d6c22166793f2db1b
First added on: Feb 20, 2024