CTRI/2017/02/007959尚未招募不适用
A Randomized, Open Labeled, Placebo Controlled, Two-Arm, Parallel Group, Multi-Centric, Oral Clinical Study To Evaluate The Sns-01/16 In Healthy Adult Human Female Volunteers Under Fasting Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- monitor safety and tolerability
研究概览
简要总结
To evaluate the tolerability, safety and compliance of treatment of SNS-01/16 in 20 randomized, open labeled, placebo controlled, two-arm, parallel group, healthy adult human female volunteers under fasting conditions. total study duration is 100 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Normal, healthy, adult, female human subjects of age between 18-65 years with a Body Mass Index (BMI) ranges between 18.5 kg/m2 to 29.9 kg/m2
- •Ability to provide written informed consent prior to participation in the study.
- •Subjects who have no evidence of underlying disease during screening and day 01 dosing and whose screening is performed within 07 days of day 01 dosing .
- •Subjects whose screening laboratory values are within normal limits or considered by the physician or 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 systems) and vital sign assessments.
- •Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
- •Non- smokers or ex-smokers.
- •Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
- •Willing to comply to all requirements of this study protocol as well as instructed by the study personnel 9.
排除标准
- •History of allergy or hypersensitivity reactions to SNS-01/16 or any related compound at any dose.
- •Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment 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, diabetes, psychosis or any other body system.
- •History of alcohol addiction or abuse.
- •History of difficulty in swallowing.
- •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 dosing.
- •Subjects demonstrating a positive pregnancy screen.
- •Subjects whose menstruation cycle coincides with the study periods
- •Subjects who are currently lactating.
- •Subjects likely to become pregnant during conducting of the study
- •Use of hormone replacement therapy for a Period of 06 months prior to dosing.
结局指标
主要结局
monitor safety and tolerability
时间窗: Visit 02, 03, 04, 05
次要结局
- to monitor body weight and Hair loss percentage(Visit 01, 02, 03, 04 and 05)
研究者
研究点 (1)
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