An Open Label Balanced Randomized Single Dose Two Treatment Three Sequence Three Period Truncated Partial Replicate, Reference scaled Average Oral Bioequivalence Study Comparing Elacestrant 345 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt Ltd India with ORSERDU Elacestrant 345 mg film coated tablet Manufactured by Stemline Therapeutics B V Basisweg 10 1043 AP Amsterdam The Netherlands In Healthy Human Male and Post Menopausal Female Subjects Under Fed Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To assess the Bioequivalence on Elacestrant 345 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt Ltd India with ORSERDU Elacestrant 345 mg film coated tablet Manufactured by Stemline Therapeutics B V Basisweg 10 1043 AP Amsterdam The Netherlands In Healthy Human Male and Post Menopausal Female Subjects Under Fed Conditions
研究概览
简要总结
At least 42 number of healthy, Human Male and Post Menopausal Female 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 42 subjects in period I alone.
Note: If needed the study will be conducted as batch wise
In each period, subjects will be housed in the clinical facility for at least 11.00 hours pre-dose to 72.00 hours post-dose. A washout period of at least 18 days will be maintained between each dosing period
In each period, after an overnight fasting of at least 10.00 hours prior to high-fat, high-calorie non veg breakfast. In the morning high-fat, high-calorie non veg breakfast will be provided 30 minutes before dosing. After consumption of breakfast, 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
Blood pressure, radial pulse rate, body temperature and wellbeing status will be enquired and recorded at pre-dose 00.00 hour (within 75 minutes of before dosing) and at 03.00, 06.00, 12.00, 24.00, and 48.00 hours (± 60 minutes) post-dose
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Normal healthy Human Male and Post Menopausal Female subjects of age between 18-60 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 30.00 kg/m2 (according to the formula BMI = weight (kg) height (m)2 Female Subjects should have at least 12 month of amenorrhea Postmenopausal status confirmed by Screening Estradiol 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 non 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 Subjects should have protected sexual contact including dose interruptions by using a latex or synthetic condom every time they have sexual intercourse with a female of reproductive potential during study and for 02 weeks after receiving their last dose of Elacestrant even if they have undergone a successful vasectomy.
排除标准
- •Evidence of allergy or known hypersensitivity to Elacestrant 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 any unusual diet, for whatever reason e.g. 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 who are are likely to become pregnant during the course of the study.
结局指标
主要结局
To assess the Bioequivalence on Elacestrant 345 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt Ltd India with ORSERDU Elacestrant 345 mg film coated tablet Manufactured by Stemline Therapeutics B V Basisweg 10 1043 AP Amsterdam The Netherlands In Healthy Human Male and Post Menopausal Female Subjects Under Fed Conditions
时间窗: 28 Time Points | 00 00 hrs 00 17 hrs 00 33 hrs 00 50 hrs 00 67 hrs 00 83 hrs 01 00 hrs 01 33 hrs 01 67 hrs 0 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 33 hrs 04 67 hrs 05 00 hrs 05 50 hrs 06 00 hrs 08 00 hrs 12 00 hrs 16 00 hrs 24 00 hrs 36 00 hrs 48 00 hrs and 72 00 hrs
次要结局
- To monitor the safety and tolerability of test product comparing with the reference product in healthy Human Male and Post Menopausal Female subjects under fed conditions(28 Time Points)
研究者
Dr Pradeep T
Spinos Lifescience and research private limited