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.

Epilepsy Clinical Trial

Official title: 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.

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

A single-center, randomized, open, two-cycle, double-crossover, fasting trial design method was used. All subjects were required to sign an informed consent form prior to participation in the trial. Physical screening was performed from day -7 to day -1 of dosing, and 24 healthy subjects (containing both male and female subjects with appropriate gender ratio) who passed the screening were randomly divided into 2 groups, T-R group and R-T group, with 12 subjects in each group. The enrolled subjects were admitted to the phase I ward of the clinical research center 1 day before each cycle of dosing and fasted for more than 10 h before each cycle of dosing.

On the morning of the dosing day, after the blank blood sample collection was completed, group T received 1 tablet (100mg/tablet, Overseas Pharmaceutical,Ltd.) of lacosamide extended-release tablets developed by Overseas Pharmaceutical,Ltd. orally; group R received 1 tablet (50mg/tablet, VIMPAT®, UCB) of lacosamide orally while administering 240ml of warm water, and again 12 hours later Lacosamide 1 tablet (50mg/tablet, VIMPAT®, UCB). Standard lunch was consumed 4h after the first dose and standard dinner was consumed 10h later. No water (except 240ml of water for dosing) was allowed before and 1h after dosing, and a uniform diet was required during the trial. The second cycle was conducted in the same way as the first cycle of the test, with an elution period of 7 days.

PK blood collection and blood sample handling. For the test preparation. Before (0h) and 0.25h, 0.50h, 1.00h, 1.50h, 2.00h, 4.00h, 5.00h, 6.00h, 7.00h, 8.00h, 10.00h, 12.00h, 14.00h, 16.00h, 18.00h, 20.00h, 24.00h, 36.00h, 48.00h, 60.00h, and 72.00h for a total of 21 time points for elbow venous blood collection.

For the reference formulation. Blood was collected at 0.25h, 0.50h, 1.00h, 1.50h, 2.00h, 3.00h, 4.00h, 6.00h, 8.00h, 12.00h, 12.50h, 13.00h, 13.50h, 14.00h, 15.00h, 16.00h, 18.00h, 20.00h, 24.00h, 36.00h and 72.00h before (0h) and after dosing. 24.00h, 36.00h, 48.00h, 60.00h, and 72.00h. A total of 23 time points of elbow venous blood was collected, 4.0 ml of blood was drawn (blood collection tubes were pre-labeled with a 4 ml scale), placed in labeled EDTA-2K anticoagulation tubes, and immediately after blood collection, the blood collection tubes were gently and completely inverted three times and mixed with anticoagulant and immediately placed in an ice-water bath at 4°C for After the centrifugation operation, the samples were removed from the centrifuge and the plasma was taken from the crushed ice surface and promptly dispensed into the corresponding labeled EP tubes in 2 tubes (test tube and backup tube), both the test tube and the backup tube were no less than 500 μL. The plasma was temporarily frozen in the -20℃ refrigerator and transferred to the -80℃ refrigerator for storage after the 72h blood collection.

Vital signs (including temperature, pulse and blood pressure) were measured in the sitting position 1 hour before and 2±0.5h, 8.0h±0.5h, 24±0.5h and 48±0.5h after dosing. Physical examination, vital signs, electrocardiogram and laboratory tests were performed when the subjects were ready to leave the group after the last dose of blood was collected. Subjects were observed and asked about their subjective perceptions and possible adverse reactions and events during the course of the study. All subjects will be followed up 10 days after the end of the last dose and asked if any subsequent adverse events occurred and if AE occurred, the AE should be recorded and followed up. If an AE occurs during the trial, follow-up until the end of the AE is required.

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Related Conditions & MeSH terms

• Epilepsy

• NCT number: NCT05788159
• Study type: Interventional
• Source: Overseas Pharmaceuticals, Ltd.
• Contact: Dr. Huaihan Cai, Director of Medical Affairs
• Phone: +8618352616957
• Email: caihuaihan@overseaspharm.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2023
• Completion date: July 31, 2023