An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioequivalence Study Comparing Elobixibat 5 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt Ltd India With Goofice® Elobixibat 5 mg Tablet Marketing Authorisation Holder EA Pharma Co Ltd Head Office 2 1 1 Irifune Chuo KU Tokyo Plant Fukushima Plant 103 1 Shirasakaushishimizu Shirakawa Shi Fukushima Japan 961 0835 In Healthy Adult Human Subjects Under Fasting Condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To assess the Bioequivalence on Elobixibat 5 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt Ltd India With Goofice® Elobixibat 5 mg Tablet Marketing Authorisation Holder EA Pharma Co Ltd Head Office - 2 1 1 Irifune Chuo KU Tokyo Plant Fukushima Plant 103 1 Shirasakaushishimizu Shirakawa Shi Fukushima Japan 961 0835 In Healthy Adult Human Subjects Under Fasting Condition
研究概览
简要总结
At least 32 subjects as this Bioequivalence study will be conducted on Healthy Adult Human Subjects Under Fasting Conditions
As per the discretion of Investigator additionally a sufficient number of stand-by subjects will be included to ensure successful dosing of 32 subjects in period I
In each period subjects will be housed in the clinical facility for at least 11.00 hours pre dose to 24.00 hours post-dose and the washout period of at least 03 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 test product T or reference product R will be administered with 240 mL of drinking water as per randomization schedule
Blood pressure radial pulse rate body temperature and wellbeing status will be enquired and recorded at pre-dose 00.00 hour within 75 minutes before dosing and at 03.00 06.00 and 12.00 ±60 minutes after completion of the dosing
Physical examination Vitals will be recorded before check-in check-out 24.00 hours of 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 male and female 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 or considered by the physician or principal or 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 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 initiation of the study & a negative urine pregnancy test prior to check-in of each period If 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 subjects last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of non-childbearing potential defined as greater or equal to 01 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 Elobixibat 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 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 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 assess the Bioequivalence on Elobixibat 5 mg Tablet Manufactured by BDR Pharmaceuticals International Pvt Ltd India With Goofice® Elobixibat 5 mg Tablet Marketing Authorisation Holder EA Pharma Co Ltd Head Office - 2 1 1 Irifune Chuo KU Tokyo Plant Fukushima Plant 103 1 Shirasakaushishimizu Shirakawa Shi Fukushima Japan 961 0835 In Healthy Adult Human Subjects Under Fasting Condition
时间窗: 22 Time Points | 00 00 hrs 00 17 hrs 00 33 hrs 00 67 hrs 01 00 hrs 01 33 hrs 01 67 hrs 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 50 hrs 05 00 hrs 06 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 16 00 hrs and 24 00 hrs
次要结局
- To monitor the safety and tolerability of single dose administered In Healthy Adult Human Subjects Under Fasting Condition(22 Time Points)
研究者
Dr Pradeep T
Spinos Lifescience and research private limited