A Randomized, Open Label, Balanced, Two Treatment, Two period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Clonazepam mouth dissolving tablets 2 mg of Abbott Healthcare Pvt ltd., with Clonazepam 2 mg immediate release tablets of Abbott Healthcare Pvt ltd., in Normal, Healthy, Adult, Male and Female Human Subjects under Fasting Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To demonstrate the bioequivalence between Test Product (T): Clonazepam Mouth Dissolving Tablets 2 mg and Reference Product (R): Clonazepam 2 mg Immediate Release Tablet in normal, healthy, adult, male and female human subjects, under fasting conditions.
研究概览
简要总结
Clonazepam is indicated for the treatment of myoclonic and a kinetic seizures and petit mal variant (Lennox-Gastaut syndrome). The recommended dose range of Clonazepam tablets is 2 mg once daily with or without food. The safety and efficacy of Clonazepam tablets 2 mg when given as a single dose, in healthy volunteers is established through various clinical studies. As per the literature single oral dose of Clonazepam tablets 2 mg results in quantifiable levels. The present study will be conducted under fasting condition based on the recommendation of regulatory authority. This dose is expected to be well tolerated and will provide sufficient plasma concentrations to measure. Based on this rationale, the current study has been designed.
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
- •1.Male and non pregnant female human subjects, age in the range of 18 – 45 years both inclusive.
- •2.Body Mass Index between 18.5-30 Kg / m2 extremes included.
- •3.Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and body temperature).
- •4.Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis, 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 after the last blood sample collection in each study period and adherence to food, fluid and posture 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 (Appendix B) for the last 06 months.
- •8.Non smokers as evident from the history obtained will be included.
排除标准
- •1.Known history of hypersensitivity to Clonazepam or related drugs.
- •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 IMP.
- •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, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- •6.Participation in a clinical drug study or bioequivalence study 90 days prior to period I dosing of the present study.
- •7.History of malignancy or other serious diseases.
- •8.Blood donation 90 days prior to period I dosing of the present study.
- •9.Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
- •10.Found positive in breath alcohol test.
- •11.Found positive in urine test for drug abuse.
- •12.History of problem in swallowing.
- •13.Any contraindication to blood sampling.
- •14.Female subjects found positive serum (β) Beta- hCG (Human Chorionic Gonadotropin) test.
- •15.Lactating women (currently breast feeding).
- •16.Female subjects not confirming to using birth control measures, from the date of screening until the completion of the study.
- •Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
- •17.Use of hormonal contraceptives either oral or implants.
结局指标
主要结局
To demonstrate the bioequivalence between Test Product (T): Clonazepam Mouth Dissolving Tablets 2 mg and Reference Product (R): Clonazepam 2 mg Immediate Release Tablet in normal, healthy, adult, male and female human subjects, under fasting conditions.
时间窗: Total number of blood samples: 23 per period. | Sampling hrs: Pre dose (collected within 01.00 hour prior to dosing), 00.25, 00.50, 00.75, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose.
次要结局
- To monitor the safety and tolerability of a single oral dose of investigational medicinal products (IMPs).(Total number of blood samples: 23 per period.)