A randomized, double blind, two-way crossover clinical trial to evaluate of pharmacokinetic profiles of lacosamide in Korean subjects

Not Applicable

Completed

Conditions: Diseases of the nervous system

Registration Number: KCT0003959

Lead Sponsor: Dong-A University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 48

Inclusion Criteria

1.A healthy Korean adult aged between 19 (inclusive) and 45 (inclusive) at the time of the screening.
2.A subject with a body weight over 55 kg (inclusive) and with a body mass index (BMI) between 18.0 (inclusive) and 30.0 (inclusive).
? BMI (kg/m2) = weight (kg) / {height (m)}2
3.A subject without any congenital or chronic diseases that require treatment or any abnormal symptoms or findings after the physical examinations
4.A subject whose results of vital signs measurement, 12-lead ECG and clinical laboratory test including serology, hematology, blood chemistry, urinalysis screening would permit inclusion.
5.A subject who is willing to participate in the study and observe the compliance details after receiving detailed explanations and fully understanding the study procedures.

Exclusion Criteria

1. A subject who has any clinically significant hepatic, renal, neurologic, respiratory, endocrine, blood tumor, urinary, cardiovascular, musculoskeletal or psychotic disease, or any of the following past or present medical history:
1) A subject who has any medical histories of mental disorders including signs, expressions or relapses of depression, abnormal mood and suicidal tendency
2) A subject who has experience of accidental injury or falling down as regards dizziness
3) A subject who has abnormalities of cardiac conduction and cardiac impulse
2. A subject with a history of gastrointestinal system disease (e.g. Crohn’s disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (except for simple appendectomy or the repair of a hernia) that influences the absorption of investigational product.
3. A subject with hypersensitivity or a history of clinically significant hypersensitivity(Photoallergy or Phototoxic) to drugs including Lacosamide and other drugs (Fibrate, Ketoprofen, Asprin, Antibiotics and so on).
4. A subject with any of the following clinically significant findings at the time of the screening:
? QTc > 450 msec
? PR interval > 200 msec
? QRS duration > 120 msec
5. A subject who has the results that 1.5 times the upper limit of the reference range at laboratory test or abnormal findings by investigator’s judgement(when test results are judged to be caused by clinically insignificant diurnal changes, they could be confirmed through follow-ups)
6. A subject who takes medicine after being diagnosed hypertension or has the following vital signs measured after taking a rest for at least 3 minutes in sitting position at the time of the screening :
SBP < 90 mmHg or DBP < 60 mmHg; SBP > 140 mmHg or DBP > 90 mmHg; H/R < 40 beats/min or >100 beats/min;
7. A subject who has taken any prescribed medication or herbal compound within 2 weeks or any over-the-counter drug or vitamin supplement within 1 week prior to the day of the first administration of investigational product (however, if, the drugs consumed are determined to have no influence the pharmacokinetic characteristics of investigational product, the subjects who have taken those drugs can participate in the study at the discretion of the investigator).
8. A subject who has participated in any other clinical trials or bioequivalence study and has had medication within 3 months prior to the day of the first administration of investigational product (the exit criterion for the other clinical trials is the day of the last administration).
9. A subject who has donated whole blood within 2 months or blood components within 1 month or received a blood transfusion within 1 month prior to the day of the first administration of investigational product.
10. A subject who consistently consumes more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) within 6 months prior to the first day of administration of investigational product or is unable to stop drinking during the study period.
11. A smoker who consumes, on average, more than 10 cigarettes a day for the most recent 3 months and who is unable to stop smoking from 48 hours prior to the administration of investigational product until the point of the last blood sampling in each period.
12. A subject who has consumed or is unable to stop consuming foods containing grapefruit from 48 hours prior to the first administration to the end of the study period.
13. A subject who has consumed