None listed
Conditions
Interventions
Intervention1: ThymoPro 50 mg: In each period, subjects will be housed in the clinical facility for at least 11.00 hours pre-dose to 72.00 hours post-dose (From the Day 01 dosing) and the washout peri
Sponsors
Verdant Nature
Eligibility
Inclusion criteria
Inclusion criteria: Normal, healthy, adult, human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2to 29.99 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 systems) and vital sign assessments. No pre-existing medical conditions and history: Obesity, Genetic, mental/emotional/behavioral diagnosis. Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments. Non smoker. Willing to consume Ovo lacto vegetarian diet. (All meals free of turmeric, black pepper, Ginger and any related marketed spice mixtures). Willing to comply with all requirements of this study protocol as well as instructed by the study personnel. 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. Female with regular menstrual cycle. Females of childbearing potential, 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 subjects last study-related visit.
Exclusion criteria
Exclusion criteria: Evidence of allergy or known hypersensitivity to Resveratrol, Berberine, Tributyrin, Thymoquinone, Quercetin 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 (i.e. coffee, tea, chocolate and caffeine-containing sodas, colas, 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, any over the counter medicinal products or illicit drugs for 30 days prior to check-in and throughout the study. Subjects who have taken supplements for 07 days prior to check-in 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 each 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the Comparative Oral Bioavailability Of the test product in healthy, adult, human subjects under fasting conditionsTimepoint: 21 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety, tolerability and adverse events of a single dose of Multi-Treatment (test and reference drugs) administered in Healthy Adult Human Subjects Under Fasting ConditionsTimepoint: 21 Days | — |
Countries
India
Contacts
Public ContactDivya Chandradhar
BioAgile therapeutics Private Limited
Outcome results
None listed