A randomized, open label, balanced, two treatment, two period, two sequence, single dose, crossover, truncated bioequivalence study of Test product (T): Cenobamate 12.5 mg Tablets of Eris Lifesciences Limited India with Reference product (R): XCOPRI® (cenobamate) 12.5 mg tablet Manufactured for SK Life Science, Inc., Paramus in Normal, 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
- 28
- 试验地点
- 1
- 主要终点
- Cmax, AUC(0-72) 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. Investigational products must be swallowed as whole and must not be chewed, crushed or divided. This activity will be followed by mouth check of the subjects to assess compliance to dosing. Principal investigator/ Clinical Investigator/ Clinical Co-Investigator/designee will oversee the dosing activity. Quality Assurance (QA) personnel will independently monitor the dosing activity. Total number of blood samples: 23 samples per period. Sampling: Pre dose 00.00 hr. [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 4.50, 05.00, 05.50, 06.00, 08.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose. Blood samples will collected in K2EDTA Vacutainer.
Subjects will be fast overnight from at least 08.00 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. At all other times drinking water will be given ad-libitum. Subjects will remain in supine position for at least 06.00 hours after dosing. Only necessary movement will be allowed during this period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •(1) Healthy human subjects, age in the range of
- •45 years both inclusive. (2) Body Mass Index between 18.5-30.0 Kg/m2 extremes included with minimum of 50 kg weight. (3) Subjects with normal findings as determined by baseline history, physical examination and vital sign examination. (4) Subjects with clinically acceptable findings as determined by haemogram, biochemistry including serum potassium, urinalysis, urine pregnancy test (for female subjects only), 12 lead ECG and chest X-ray (if done). (5) 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. (6) No history of significant alcoholism. (7) No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 06 months. (8) Non-smokers as evident from the history obtained. (9) Willing to provide written informed consent to participate in the study.
排除标准
- •(1) Known history of hypersensitivity to Cenobamate or related drugs or any of the excipients.
- •(2) Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days prior to dosing day.
- •(3) Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of IP.
- •(4) Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- •(5) History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- •(6) Not eligible as per Online Volunteer Information System (OVIS).
- •(7) Volunteer who have donated blood or experienced loss of blood of up to 150 ml within 30 days or 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.
- •(8) History of malignancy or other serious diseases.
- •(9) History of hypersensitivity reactions including rash papular and pruritus.
- •(11) Found positive in Columbia-Suicide Severity Rating Scale.
- •(12) Found positive in breath alcohol test and/or urine test for drug abuse.
- •(13) History of problems in swallowing of tablet/capsule.
- •(14) Any contraindication to blood sampling.
- •(15) Male human subjects not willing to use birth control measures, from the period-I dosing until the completion of the study.
- •(16) Use of hormonal contraceptives either oral or implants.
结局指标
主要结局
Cmax, AUC(0-72) and AUC(0-inf)
时间窗: Total number of blood samples: 23 samples per period. Pre dose 00.00 hr. [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 4.50, 05.00, 05.50, 06.00, 08.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose.
次要结局
- AUC% extrapolation, Kel, Tmax and t1/2(Total number of blood samples: 23 samples per period. Pre dose 00.00 hr. [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 4.50, 05.00, 05.50, 06.00, 08.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose.)
研究者
Dr Nirav Panchal
Sycon Clinical Research Pvt Ltd.