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.
1 other identifier
interventional
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2023
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2023
CompletedFirst Posted
Study publicly available on registry
March 28, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedMarch 28, 2023
March 1, 2023
3 months
March 15, 2023
March 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last)
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-last within \[0.8, 1.25\] range will be used to determine the result of bioequivalence.
Time Frame: 1 month
Area under the curve from time zero to infinity (AUC0-inf)
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of AUC0-inf within \[0.8, 1.25\] range will be used to determine the result of bioequivalence.
Time Frame: 1 month
Peak concentration at each treatment period (Cmax,tp)
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of Cmax,tp within \[0.8, 1.25\] range will be used to determine the result of bioequivalence.
Time Frame: 1 month
Secondary Outcomes (4)
Peak concentration of the first dosing (Cmax)
Time Frame: 1 month
Time to reach peak concentration of the first dosing (Tmax)
Time Frame: 1 month
Terminal half-life (T1/2)
Time Frame: 1 month
Mean residence time (MRT)
Time Frame: 1 month
Study Arms (2)
Lacosamide extended release tablets
EXPERIMENTALTest 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.
Lacosamide Tablets
ACTIVE COMPARATORReference 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
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Healthy male and female subjects aged 18 to 60 years old (including 18 and 60 years old) with appropriate sex ratio.
- 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.
- Good health status, no abnormalities with clinical manifestations in the respiratory, circulatory, digestive, urinary, hematological, endocrine, immune, neurological, or psychiatric systems.
- 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.
- 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.
You may not qualify if:
- 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.
- Those who have special dietary requirements and cannot accept a uniform diet
- those with a history of dysphagia or any gastrointestinal disorder that affects drug absorption
- those who cannot tolerate venipuncture and those who suffer from needle sickness and blood dizziness
- clinically significant hematological, endocrine, cardiovascular, hepatic, renal, or pulmonary diseases that may affect drug absorption, distribution, metabolism, or excretion
- history of surgical procedures or having taken study drugs or participated in other drug clinical trials within 3 months prior to the study
- blood donation or significant blood loss (\>450 ml) within 3 months prior to the study
- 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
- have taken any prescription medication (including birth control pills) within 14 days prior to the administration of the study drug
- have taken any over-the-counter medication, herbal or nutraceutical product (except contraceptives) within 14 days prior to taking the study drug
- 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)
- Those who smoked more than 5 cigarettes per day in the 3 months prior to the study and did not pass the nicotine screen.
- 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
- Those who have consumed any alcohol-containing product or screened positive for alcohol within 48 hours prior to taking the study drug
- Female subjects who have a positive pregnancy test or are breastfeeding during the screening period or during the trial
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2023
First Posted
March 28, 2023
Study Start
April 1, 2023
Primary Completion
June 30, 2023
Study Completion
July 31, 2023
Last Updated
March 28, 2023
Record last verified: 2023-03