CTRI/2024/08/073072尚未招募不适用
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Four Period Crossover Fully Replicate Reference Scaled Oral Bioavailability Study Comparing Clopidogrel 75 Mg In 5 Ml Oral Suspension Manufactured For Mahashiv Limited Uk With Plavix® Clopidogrel Bisulfate 75 Mg Film Coated Tablets Distributed By Sanofi Aventis Groupe 54 Rue La Boetie F 75008 Paris Frankreich Eu/1/98/069/004 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 36 人开始时间: 2024年9月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To assess the Bioavailability on Clopidogrel 75 mg in 5 mL Oral Suspension Manufactured For Mahashiv Limited Uk With Plavix® Clopidogrel Bisulfate 75 mg Film Coated Tablets Distributed by Sanofi Aventis Groupe 54 Rue La Boetie F 75008 Paris Frankreich 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 36 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 36 subjects in period I
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 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 and vital sign assessments Generally healthy as documented by 12 lead electrocardiogram 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 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 subject last study related visit.
排除标准
- •Evidence of allergy or known hypersensitivity to Clopidogrel Bisulfate 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 which might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and or Xanthine containing products 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 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 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 start of 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 likely to become pregnant during conduction of the study.
结局指标
主要结局
To assess the Bioavailability on Clopidogrel 75 mg in 5 mL Oral Suspension Manufactured For Mahashiv Limited Uk With Plavix® Clopidogrel Bisulfate 75 mg Film Coated Tablets Distributed by Sanofi Aventis Groupe 54 Rue La Boetie F 75008 Paris Frankreich In Healthy Adult Human Subjects Under Fasting Conditions
时间窗: 00.17 Hrs 00.33 Hrs 00.50 Hrs 00.67 Hrs 00.83 Hrs 01.00 Hrs 01.25 Hrs 01.50 Hrs 01.75 Hrs 02.00 Hrs 02.50 Hrs 03.00 Hrs 03.50 Hrs 04.00 Hrs 05.00 Hrs 06.00 Hrs 08.00 Hrs 10.00 Hrs 12.00 hrs 24.00 Hrs 36.00 Hrs
次要结局
- To monitor the safety and tolerability in healthy adult human subjects under fasting conditions(00.17 Hrs 00.33 Hrs 00.50 Hrs 00.67 Hrs 00.83 Hrs 01.00 Hrs 01.25 Hrs 01.50 Hrs 01.75 Hrs 02.00 Hrs 02.50 Hrs 03.00 Hrs 03.50 Hrs 04.00 Hrs 05.00 Hrs 06.00 Hrs 08.00 Hrs 10.00 Hrs 12.00 hrs 24.00 Hrs 36.00 Hrs)
研究者
Dr Pradeep T
Spinos Lifescience and research private limited
研究点 (1)
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