An Open Label Balanced Randomized Single Dose Two Treatment Two Period Two Sequence Two Way Cross Over Truncated Oral Bioequivalence Study Comparing Enzalutamide 80 mg Tablets Manufactured by BDR Pharmaceuticals Internationals Pvt Ltd India With Xtandi Enzalutamide 80 mg Tablets Manufactured by Patheon Inc 2100 Syntex Court Mississauga Ontariom Canada Packed by Astellas Pharma Europe B V Hogematt 2 7942 JG Meppel Holanda Imported by Astellas Farma Brasil Importacao E Distribuicao de Medicamentos Ltda Avenida Guido Caloi 1 935 Bloco B 2 Andar Sao Paulo SP CNPJ 07 768 134 0001 04 In Healthy Adult Human Male Subjects Under Fasting Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To assess the bioequivalence of Enzalutamide 80 mg Tablets Manufactured by BDR Pharmaceuticals Internationals Pvt Ltd India With Xtandi Enzalutamide 80 mg Tablets Manufactured by Patheon Inc Canada Packed by Astellas Pharma Europe Holanda Imported by Astellas Farma Brasil Sao Paulo In Healthy Adult Human Male Subjects Under Fasting Conditions
研究概览
简要总结
Enough volunteer shall be recruited in order to evaluate and start the study with at least 18 subjects, as this bioequivalence study will be conducted on healthy, adult, human male subjects.
As per the discretion of the Investigator, a sufficient number of stand-by subjects will be included additionally to ensure successful dosing of 18 subjects in period I.
Note: latex or synthetic condom will be provided at each period check out.
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, with a washout period of at least 14 days from the successive dosing day.
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 randomization.
Physical examination, Vitals will be recorded before check-in, check-out (72.00 hours) for each period and at any time if necessary.
ECG will be recorded before the check out for each Period or after any subject is withdrawn or dropped out from the study.
Statistical analyses will be done using SASsystem for windows version 9.4 or above (SAS® Institute Inc., USA) or applicable software.
St
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 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Normal healthy adult human male subjects of age above 18 to 45 years and Body Mass Index BMI ranges between 18 50 kg/ per m2 to 29 99 kg per 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 systems 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 instructions from the study personnel Non smokers Subjects willing to use adequate contraception during sexual intercourse with female partners of child bearing potential during the study and for a period of 03 months after receiving last dose of Enzalutamide.
排除标准
- •Evidence of allergy or known hypersensitivity to Enzalutamide 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 on going chronic medical illness Renal or liver impairment History of or risk factors for seizure 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 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 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 180 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 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.
结局指标
主要结局
To assess the bioequivalence of Enzalutamide 80 mg Tablets Manufactured by BDR Pharmaceuticals Internationals Pvt Ltd India With Xtandi Enzalutamide 80 mg Tablets Manufactured by Patheon Inc Canada Packed by Astellas Pharma Europe Holanda Imported by Astellas Farma Brasil Sao Paulo In Healthy Adult Human Male Subjects Under Fasting Conditions
时间窗: 26 samples | 00 00 hrs 00 25 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 25 hrs 01 50 hrs 01 75 hrs 02 00 hrs 02 25 hrs 02 50 hrs 03 00 hrs 03 50 hrs 04 00 hrs 04 50 hrs 05 00 hrs 05 50 hrs 06 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 16 00 hrs 24 00 hrs 36 00 hrs 48 00 hrs 72 00 hrs
次要结局
- To monitor the safety and tolerability of healthy adult human male subjects under Fasting conditions(26 samples)
研究者
Dr Pradeep T
Spinos Life science and research private limited