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.

Cholayil Pvt Ltd0 个研究点目标入组 20 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. 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
•2. Ability to provide written informed consent prior to participation in the study.
•3. 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 .
•4. Subjects whose screening laboratory values are within normal limits or considered by the physician or investigator to be of no clinical significance.
•5. 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.
•6. Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
•7. Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
•8. Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
•9. Subjects within normal limits or clinically non-significant laboratory evaluation results for FSH & LH.

•1. History of allergy or hypersensitivity reactions to SNS-01/16 or any related compound at any dose.
•2. Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
•3. Any major illness in the last three months or any significant ongoing chronic medical illness.
•4. Renal or liver impairment.
•5. 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.
•6. History of alcohol addiction or abuse.
•7. History of difficulty in swallowing.
•8. Any blood donation / excess blood loss within 90 days of check-in.
•9. Ingestion of any hormonal agent at any time within 14 days prior to start of dosing.
•10. Subjects demonstrating a positive pregnancy screen.
•11. Subjects whose menstruation cycle coincides with the study periods
•12. Subjects who are currently lactating.
•13. Subjects likely to become pregnant during conducting of the study
•14. Use of hormone replacement therapy for a Period of 06 months prior to dosing.

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