A Randomized, open label, balanced, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Test product (T): Lacosamide SR 200 mg Tablet of Eris Lifesciences Limited India with Reference product (R): MOTPOLY XR (Lacosamide Extended Release) Capsules 200 mg Marketed by Aucta Pharmaceuticals, Inc. Piscataway in healthy, adult, human subjects under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax, AUC(0-t) and AUC(0-inf)
研究概览
简要总结
A single oral dose of Test product (T) or Reference product (R) will be administered as per randomization schedule with 240 mL ± 2 mL of water at ambient temperature under fasting condition. Subjects will be fast overnight from at least 10.00 hours (hrs) before dose administration and for at least 04.00 hrs post- dose in each study period. Water will not allowed to the subjects for 01.00 hr pre dose to 01.00 hr post dose except dosing water given during administration of the dose. Subjects will remain in supine position on bed for at least 08.00 hours after dosing. Only necessary movement will be allowed during this period.
Total number of blood samples: 25 samples per period. Sampling hrs: Pre dose [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 01.00, 02.00, 03.00, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 11.00, 12.00, 13.00, 14.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hrs. Post-dose.
After collection, the blood samples will centrifuged at 3500 RPM for 5 minutes below 10°C to separate the plasma within 60 minutes of sample collection. Total time should not be exceed 90 minutes from blood collection to storage. The separated plasma will be transferred to a pre-labeled polypropylene tube in two aliquots (Analytical and control) [around 0.4 mL in the first aliquot (0.7 mL in case of pre-dose samples) and the remaining volume in the second aliquot] and stored in the deep freezer maintained at -20°C ± 5°C or colder temperature as soon as possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy human subjects, age in the range of
- •45 years both inclusive.
- •Body Mass Index between 18.5-30.0 Kg/m2 extremes included with minimum of 48 kg weight.
- •Subjects with normal findings as determined by baseline history, physical examination and vital sign examination.
- •Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis, 12 lead ECG and chest X-ray (if done).
- •Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until the last blood sample collection in each study period and adherence to all study restrictions.
- •No history of significant alcoholism.
- •No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 06 months.
- •Non-smokers as evident from the history obtained.
- •Willing to provide written informed consent to participate in the study.
排除标准
- •Known history of hypersensitivity to Lacosamide or related drugs or any of the excipients.
- •Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- •Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of IP.
- •Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- •History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- •Not eligible as per OVIS.
- •Volunteer who have donated blood or loss of blood up to 150 ml within 30 days or more than 150 ml to 250 ml within 60 days or more than 250 ml within 90 days (exclude blood loss for screening) prior to first dose of study medication.
结局指标
主要结局
Cmax, AUC(0-t) and AUC(0-inf)
时间窗: Total number of blood samples: 25 samples per period. Sampling hrs: Pre dose [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 01.00, 02.00, 03.00, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 11.00, 12.00, 13.00, 14.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hrs. Post-dose.
次要结局
- AUC% extrapolation, Kel, Tmax and t1/2