An Open Label Balanced Randomized Single Dose Two Treatment Three Sequence Three Period Crossover Partial Replicate Reference Scaled Average Oral Bioequivalence Study Comparing Melatonin 2 Mg Prolonged Release Tablets Manufactured By Vs International Pvt Ltd India With Circadin Melatonin 2 Mg Prolonged Release Tablets Marketing Authorization Holder Rad Neurim Pharmaceuticals Eec Sarl 4 Rue De Marivaux 75002 Paris France In Healthy Adult Human Subjects Under Fasting Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To compare the rate and extent of absorption of single dose of Melatonin 2 mg Prolonged Release Tablets
研究概览
简要总结
Enough volunteers shall be recruited in order to evaluate and start the study with at least 48 subjects, as this Bioequivalence study will be conducted on healthy, adult, human subjects.
As per the discretion of the Investigator, a sufficient number of stand-by subjects will be included additionally to ensure successful dosing of 48 subjects in period I.
Study can be conducted by dividing the study subjects into groups. The subject number in the study will be allocated sequentially in each group
In each period subjects will be housed in the clinical facility for at least 36.00 hours pre-dose to 24.00 hours post-dose, with a washout period of at least 04 days from the successive dosing day.
Lighting will be standardized. Melatonin is not produced endogenously in presence of ambient light. This standardization including using same windowless room on the dosing day and will be maintained over the entire blood sampling period. Lighting in the room will be kept constant. All light readings are between 500 lux and 600 Lux. Four light meter readings will be recorded on each study periods. (in the morning 07:00 AM to 08:00 AM, in the afternoon 12:00 PM to 01:00 PM, in the evening 05:00 PM to 06:00 PM and in the night 11:00 PM to 12:00 AM).
Note: Light readings will be recorded by using Luxmeter.
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
- •Volunteers meeting all of the following criteria will be considered for enrollment in the study Normal healthy adult human subjects of age between 18 45 years and Body Mass Index BMI ranges between 18 50 kg/m2 to 30 00 kg/m2 Subjects who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in Subjects whose screening laboratory values are within normal limits are considered by the physician or principal clinical investigator to be of no clinical significance Healthy as documented by the medical history physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments Willing to consume Ovo lacto vegetarian diet Willing to comply with all requirements of this study protocol as well as instruction from the study personnel Non smokers Generally healthy as documented by gynaecological examination and breast examination for female subjects period I only Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to the initiation of the study and a negative urine pregnancy test prior to check in for each period.
排除标准
- •Volunteers with a history or significant presence of the following will be excluded from participation/enrollment in the study Evidence of allergy or known hypersensitivity to Melatonin or its inactive ingredients Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease Any major illness in the last three months or any significant ongoing chronic medical illness Renal or liver impairment Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and or xanthine containing products ie coffee tea chocolate caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48 00 hours prior to check-in and throughout the entire study Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within 48 00 hours prior to clinic admission and throughout the entire study Subjects who have taken any prescription medications within 14 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check in and throughout the study Subjects who have taken an unusual diet for whatever reason low salt for 48 00 hours prior to dosing and throughout the study Subject who had participated in any other study within the 90 days of check in History of difficulty in swallowing History of difficulty in accessibility of veins Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check in of this study period Positive results for alcohol test prior to check in of each period Any blood donation excess blood loss within 90 days of check in Ingestion of any hormonal agent at any time within 14 days prior to the start of the study check in Use of hormone replacement therapy for a period of 06 months prior to dosing Female subjects demonstrating a positive pregnancy screen Female subjects who are currently lactating Females are likely to become pregnant during the course of the study.
结局指标
主要结局
To compare the rate and extent of absorption of single dose of Melatonin 2 mg Prolonged Release Tablets
时间窗: 22 blood samples | -24.00 hrs -20.00 hrs -16.00 hrs -12.00 hrs -10.00 hrs | 00.00 hrs 00.33 hrs 00.67 hrs 01.00 hrs 01.50 hrs | 02.00 hrs 02.50 hrs 03.00 hrs 03.50 hrs 04.00 hrs | 05.00 hrs 06.00 hrs 08.00 hrs 10.00 hrs 12.00 hrs | 14.00 hrs and 24.00 hrs
次要结局
- To evaluate the safety and tolerability of a single dose of Melatonin 2 mg prolonged release tablets in healthy adult human subjects under fasting conditions(22 blood samples)
研究者
Dr Pradeep T
Spinos Life science and research private limited