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.

CS3156

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.

2023-04-01

2023-06-30

2023-07-31

Not yet recruiting

Early phase I

16

Inclusion Criteria: 1. Healthy male and female subjects aged 18 to 60 years old (including 18 and 60 years old) with appropriate sex ratio. 2. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; body mass index (BMI) within the range of 19\~26.0 kg/m2 (including the critical value). BMI = weight (kg)/\[height (m)\]2. 3. Good health status, no abnormalities with clinical manifestations in the respiratory, circulatory, digestive, urinary, hematological, endocrine, immune, neurological, or psychiatric systems. 4. Subjects (including partners) have no plans to become pregnant and voluntarily use appropriate contraception from 2 weeks prior to screening until 6 months after the end of the study. 5. Subjects who are able to communicate well with the investigator and who understand and comply with the requirements of this study. Subjects who fully understand the purpose, nature, methods, and possible adverse effects of the trial, volunteer to be a subject, and sign an informed consent form prior to the start of any study procedures. Exclusion Criteria: 1. Persons with a history of allergy to the study drug or its excipients (e.g. lactose), or allergy to drugs, food, pollen or with a history of specific allergies (asthma, allergic rhinitis, eczema), etc. 2. Those who have special dietary requirements and cannot accept a uniform diet 3. those with a history of dysphagia or any gastrointestinal disorder that affects drug absorption 4. those who cannot tolerate venipuncture and those who suffer from needle sickness and blood dizziness 5. clinically significant hematological, endocrine, cardiovascular, hepatic, renal, or pulmonary diseases that may affect drug absorption, distribution, metabolism, or excretion 6. history of surgical procedures or having taken study drugs or participated in other drug clinical trials within 3 months prior to the study 7. blood donation or significant blood loss (\>450 ml) within 3 months prior to the study 8. who have taken a special diet (including dragon fruit or grapefruit and products containing grapefruit ingredients) or had strenuous exercise or other factors affecting the absorption, distribution, metabolism, or excretion of the drug within 7 days prior to taking the study drug 9. have taken any prescription medication (including birth control pills) within 14 days prior to the administration of the study drug 10. have taken any over-the-counter medication, herbal or nutraceutical product (except contraceptives) within 14 days prior to taking the study drug 11. regular drinkers of alcohol within 6 months prior to the study, i.e. more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of spirits at 40% alcohol or 150 ml of wine) 12. Those who smoked more than 5 cigarettes per day in the 3 months prior to the study and did not pass the nicotine screen. 13. ingested chocolate, any caffeine-containing, or xanthine-rich food or beverage such as coffee, strong tea, cola, etc. 48 hours prior to taking study medication 14. Those who have consumed any alcohol-containing product or screened positive for alcohol within 48 hours prior to taking the study drug 15. Female subjects who have a positive pregnancy test or are breastfeeding during the screening period or during the trial 16. positive for hepatitis B surface antigen, positive for hepatitis C antibody, positive for HIV antibody or positive for primary syphilis screening 17. Those who screen positive for drugs or have a history of drug abuse within the past five years or have used drugs in the three months prior to the test 18. Subjects with an underlying medical, psychiatric, psychological or other inappropriate condition, poor compliance, or who, in the opinion of the investigator, are unsuitable for participation in the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.\n\nReference 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', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}

2023-03-28