NCT05788159 - 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. | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 1, 2023

Primary Completion Date

June 30, 2023

Study Completion Date

July 31, 2023

Conditions

Epilepsy

Interventions

DRUG

Lacosamide Tablets

Reference preparation (R): Lacosamide Tablets Specification: 50mg/tablet Lot No.: 7883201 Content: 50mg/tablet Expiration date: September 2026 Storage condition: not more than 30C in airtight storage Manufacturer: Aesica Pharmaceuticals GmbH

DRUG

Lacosamide extended release tablets

Test preparation (T): Lacosamide extended release tablets Specification: 100mg/tablet Lot number: 22121301 Content: 100mg/tablet Expiration date: December 12, 2024 Storage conditions: Store at 20℃\~25℃, short-term can be at 15C\~30℃ Manufacturer: Overseas Pharmaceutical,Ltd.

Trial Locations (1)

430000

Union Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan