Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Topiramate Film-coated Tablets (100 mg) relative to Topamax (Original Topiramate Film-coated Tablets (100 mg)) in healthy Thai volunteers under fasting condition

Authors
Category Primary study
Registry of TrialsTCTR
Year 2023
INTERVENTION: Experimental Drug,Active Comparator Drug The new generic products which were recently developed. A single dose of Topiramate Film‐coated Tablets (100 mg) will be given with 250 mL of water. Investigational product will be administered directly from the unit dose‐container into the open mouth of subjects.,The marketed original products which were already available in the market. A single dose of Topama X(Original Topiramate Film‐coated Tablets (100 mg)) will be given with 250 mL of water. Investigational product will be administered directly from the unit dose‐container into the open mouth of subjects. Topiramate Film‐coated Tablets (100 mg),Topama X(Original Topiramate Film‐coated Tablets (100 mg)) CONDITION: Bioequivalence Topiramate Film‐coated Tablets 100 mg Healthy subjects ; Bioequivalence Topiramate Film‐coated Tablets 100 mg 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, 2.25, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 24.00, 36.00, 48.00 and 72.00 hours pharmacokinetic parameter SECONDARY OUTCOME: Safety; Adverse events 2.0, 4.0, 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 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: 81f19422ccb157f5ac3c51d0c0cb78e2e0442430
First added on: Feb 20, 2024