An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Crossover Truncated Four Period Fully Replicate Reference Scaled Average Oral Bioequivalence Study Comparing Relugolix 120 mg Tablets Manufactured By BDR Pharmaceuticals Internationals Pvt Ltd India With Orgovyx (Relugolix) 120 MG Tablets Distributed By Sumitomo Pharma America Inc In Healthy Adult Human Male 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
- 48
- 试验地点
- 1
- 主要终点
- To assess the Bioequivalence on Relugolix 120 mg Tablets
研究概览
简要总结
An Open-Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two Sequence, Crossover, Truncated, Four-Period, Fully Replicate, Reference Scaled Average Oral Bioequivalence Study Design.
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 male subjects.
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 and the washout period of at least 21 days from the successive dosing day.
After collection of blood samples from all the subjects at each time point, study personnel will place the collected samples in a thermo-insulated box containing wet ice and transfer the box to the sample processing room where the blood samples will be centrifuged at 4000 ± 50 RPM for 10 minutes at 02°C to 08°C to separate the plasma. Centrifugation will start within 30 minutes of the collection of samples, at each collection time-point. The resulting plasma will be equally transferred to pre-labeled polypropylene tubes into two aliquots.
The plasma samples will be then stored in a freezer at the temperature of -30 ± 10°C or -70 ± 15°C at the clinical site and bio-analytical sites.
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
- Male
入选标准
- •Normal healthy adult human male subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 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 or 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 may not be limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system) and vital sign assessments Generally healthy as documented by 12 lead electrocardiogram (ECG) Chest X Ray and clinical laboratory assessments Willing to consume Ovo lacto-vegetarian diet Willing to comply to all requirements of this study protocol as well as instructed by the study personnel If male and sexually active the subject is willing to commit to 2 acceptable methods of birth control for the duration of the study up to 14 days from the last dose.
排除标准
- •Evidence of allergy or known hypersensitivity to Relugolix or its inactive ingredients Any major illness in the last three months or any significant ongoing chronic medical illness Renal or liver impairment Consumption of caffeine and or Xanthine containing products cigarettes and tobacco containing products for at least 48.00 hours prior to check-in.
结局指标
主要结局
To assess the Bioequivalence on Relugolix 120 mg Tablets
时间窗: 22 blood samples | 00.00, 00.33, 00.67, 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, 10.00, 12.00, 24.00, 48.00, and 72.00 hours
次要结局
未报告次要终点
研究者
Dr Pradeep
Spinos Lifescience and Research Pvt Ltd