None listed
Conditions
Interventions
Intervention1: SNS-01/16: Nutritional supplime
Sponsors
Cholayil Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| monitor safety and tolerabilityTimepoint: Visit 02, 03, 04, 05 | — |
Secondary
| Measure | Time frame |
|---|---|
| to monitor body weight and Hair loss percentageTimepoint: Visit 01, 02, 03, 04 and 05 | — |
Countries
India
Contacts
Public ContactDr P Nagarajan
Spinos Life Sceience and Research Pvt Ltd
Outcome results
None listed