A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Etoricoxib 120 mg tablets relative to Arcoxia 120 mg tablets in healthy Thai volunteers under fasting condition

Authors
Category Primary study
Registry of TrialsTCTR
Year 2023
INTERVENTION: Etoricoxib 120 mg tablets,Arcoxia 120 mg tablets Experimental Drug,Active Comparator Drug The new generic products which were recently developed. Volunteer will receive a single dose of Etoricoxib 120 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 Arcoxia 120 mg tablets either test or reference with 250mL of drinking water. CONDITION: Bioequivalence Etoricoxib 120 mg tablets Healthy subjects ; Bioequivalence Etoricoxib 120 mg tablets PRIMARY OUTCOME: Cmax AUC0‐t and AUC0‐inf 0.00, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 5.00, 7.00, 9.00, 12.00, 24.00, 48.00, 72.00 and 96.00 hours post‐dose Pharmacokinetics parameter SECONDARY OUTCOME: Safety; Adverse events 1.00, 2.00, 4.00, 12.00, 24.00, 48.00, 72.00 and 96.00 hours post‐dose Safety monitoring, vital sign 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/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. 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: 389acd420112403f316e7244b95ca800e4927ae5
First added on: Feb 20, 2024