An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Two-way Crossover, Oralcomparative Pharmacokinetic(PK)Study of Lacosamide Extended-Release Tablets , Adult, Human Subjects Under Fasting Conditions.

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Two-way Crossover, Oralcomparative Pharmacokinetic(PK)Study of Lacosamide Extended-Release Tablets , Adult, Human Subjects Under Fasting Conditions. Main purpose: To the Overseas Pharmaceutical,Ltd. Developed lacoxamide slow-release tablets (specification: 100mg) for the test preparation, UCB produced rasoxamide tablets (trade name: VIMPAT®, specification: 50mg) for the reference preparation, compare the fasting state of oral test preparation and reference preparation in Chinese healthy subjects blood concentration and main pharmacokinetic parameters, to evaluate the biological equivalence of test preparation and reference preparation. Secondary objective: To evaluate the safety of the test sustained-release tablets and reference tablets in the healthy Chinese subjects.
Epistemonikos ID: bb0ae1d4526280c6921369301421a827ef268ac7
First added on: Feb 19, 2024