CTRI/2024/09/074038已完成不适用
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioavailability Study Comparing Apixaban 5 Mg Oral Solution 1mg Per Ml Manufactured By Xl Laboratories Pvt Ltd 430 Dlf Towers Shivaji Marg New Delhi 110015 India With Eliquis Apixaban 5 Mg Film Coated Tablets Marketing Authorisation Holder Bristol Myers Squibb Pfizer Eeig Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867 Ireland In Healthy Adult Human Subjects Under Fasting Conditions
Mahashiv Limited1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年10月2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
- 28
- 试验地点
- 1
- 主要终点
- To assess the Bioavailability on Apixaban 5 mg Oral Solution 1mg/mL Manufactured by XL Laboratories Pvt Ltd 430 DLF Towers Shivaji Marg New Delhi 110015 India With Eliquis Apixaban 5 mg Film Coated Tablets Marketing Authorisation Holder Bristol Myers Squibb Pfizer EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867 Ireland In Healthy Adult Human Subjects Under Fasting Conditions
研究概览
简要总结
Enough volunteers shall be recruited in order to evaluate and start the study with at least 28 subjects, as this Bioavailability study will be conducted on healthy, adult, human subjects.
As per the discretion of Investigator, additionally a sufficient number of stand-by subjects will be included to ensure successful dosing of 28 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 04 days from the successive dosing day.
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 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 Non smokers Generally healthy as documented by gynaecological examination and breast examination.
排除标准
- •Evidence of allergy or known hypersensitivity to Apixaban 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 History of alcohol addiction or abuse Consumption of caffeine and or Xanthine containing products coffee tea chocolate and caffeine containing sodas cola 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 an unusual diet for whatever reason 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 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 start of 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 Bioavailability on Apixaban 5 mg Oral Solution 1mg/mL Manufactured by XL Laboratories Pvt Ltd 430 DLF Towers Shivaji Marg New Delhi 110015 India With Eliquis Apixaban 5 mg Film Coated Tablets Marketing Authorisation Holder Bristol Myers Squibb Pfizer EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867 Ireland In Healthy Adult Human Subjects Under Fasting Conditions
时间窗: 23 blood samples | 00.00 hrs 00.25 hrs 00.50 hrs 00.75 hrs 01.00 hrs 01.33 hrs 01.67nhrs 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 12.00 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 single dose administered in healthy adult human subjects under fasting conditions(23 blood samples)
研究者
Dr Pradeep T
Spino Life science and research private limited
研究点 (1)
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