CTRI/2025/10/096666已完成不适用
An Open Label Balanced Randomized Single Dose Two Treatment Three Sequence Three Period Partial Replicate Reference scaled Average Oral Bioequivalence Study Comparing Melatonin 2 mg Prolonged Release Tablets Manufactured by V S 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
V S International Pvt Ltd1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年11月10日最近更新:
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
研究概览
简要总结
At least 48 number of healthy, adult, human subjects will be recruited to evaluate the Bioequivalence of Test product with the Reference product.
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 alone.
Note: If needed the study will be conducted as batch wise.
Standard meals will be provided starting -35.00, -23.00, -20.00, -16.00 and -12.00 pre-dose hours for each period
Standard meals will be provided at 04.00, 08.00 and 12.00 hours post-dose respectively (within +30 minutes of scheduled time). All meal plans will be identical in all the periods of the study
In each period, after an overnight fasting of at least 10.00 hours, in the morning a single oral dose of either the test product (T) or reference product (R) will be administered (as per the randomization schedule) with 240 mL of drinking water at ambient temperature
The subjects will fast for at least 10.00 hours prior to dosing and 04.00 hours post-dose.
Blood pressure, radial pulse rate, body temperature and wellbeing status will be enquired and recorded at pre-dose -21.00, -17.00 hours (±60 minutes) and 00.00 hour (within 75 minutes of before dosing) and at 01.00, 03.00, 06.00 and 11.00 hours (±60 minutes) post-dose.
Physical examination and vitals will be recorded before check-in, check-out (24.00 hours (± 60 minutes)) for each period and at any time if necessary
Monitoring for adverse events will be done throughout the study period in clinical phase
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
- •Normal healthy adult human subjects of age between 18 to 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 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 If the subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subject’s last studyrelated visit for eligible subjects only if applicable has a negative serum pregnancy test and is of non-childbearing potential defined as 1 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy or is of childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide intrauterine device IUD with a low failure rate of less than 1 percentage per year or is of childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active.
排除标准
- •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 diseas 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 checkin 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 any unusual diet for whatever reason eg 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 each period Positive results for alcohol test prior to check in of each period Any blood donation or 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.
研究者
Dr Pradeep T
Spinos Lifescience and research private limited
研究点 (1)
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