A Bioequivalence study of a randomized, single dose, two-way crossover design with two-period, two-treatment, and two-sequence of Lacosamide Film Coated Tablet 100 mg (Test) relative to Vimpat Film Coated Tablet 100 mg (Reference) in healthy Thai adult volunteers under fasting condition.
- Conditions
- Healthy subjectsBioequivalence Lacosamide Film Coated Tablet 100 mg
- Registration Number
- TCTR20240529004
- Lead Sponsor
- Bio-innova Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 30
1.Willingness to provide written informed consent prior to participate in the study.
2.Healthy Thai subjects are between 18 to 55 years of age.
3.The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2.
4.Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects safety after the completion of the study.
5.Negative urine pregnancy test for women and no breast-feeding.
6.Absence of significant diseases/disorders or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.
1.History or evidence of allergy or hypersensitivity to Lacosamide or any related drugs or any of the excipients of this product.
2.Subject with B.P. is Systolic B.P < 90, >=140 mm/Hg, Diastolic B.P < 60, >=90 mm/Hg, pulse rate > 100, < 50 beats per minute.
3.Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).*
4.Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).*
5.Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).*
6.Positive of hepatitis B or C virus or HIV.
7.12-lead ECG demonstrating PR interval <120 or >200 msec or considered clinically significant at Screening.
8.History or evidence of cardiac, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, Neurological, hematological or glaucoma
9.History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
10.Any major illness in the past 3 months or any significant ongoing chronic medical illness.
11.History of psychiatric or major depression disorder.
12.History of suicidal thoughts, behavior or suicide attempt.
13.History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
14.History of grapefruit, pomelo or grapefruit products consumption and cannot stop at least 7 days before the study drug administration and until the completion of the study.
15.History of St. John Wort product consumption and cannot stop at least 28 days before the study drug administration and until the completion of the study.
16.History of usually smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of each period of the study.
17.High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
18.Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine, Opioids and Barbiturates).
19.Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera must be discontinued at least 6 months) prior to the study drug administration.
20.History of difficulty in accessibility of veins in left and right arm.
21.Blood donation (one unit or 450 mL) within the past 3 months before the study.
22.Participation in any clinical study within the past 3 months before the study.
23.Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
(* Clinically significant laboratory values as per investigator decision)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax AUC0-t and AUC0-inf pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 9.00, 12.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose Pharmacokinetics parameter
- Secondary Outcome Measures
Name Time Method Safety; Adverse events pre-dose, at approximately 1.0, 2.0, 4.0, 6.0 12.0, 24.0, 36.0, 48.0 and 72.0 hours post-dose Safety monitoring, vital sign,Safety; Adverse events At check-in, approximately 2.0, 4.0, 6.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours post-dose Safety monitoring, asked questions to assess the suicidal,Safety; Adverse events at 3.0-6.0 hours after dosing and at 8.0-12.0 hours after dosing Safety monitoring, EKG