None listed
Conditions
Interventions
Intervention1: BAE20: Single day Oral Administration of Single dose of BAE20
Control Intervention1: UAE20: Single day Oral Administration of Single dose of UAE20
Sponsors
Akay Natural Ingredients Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1,Subjects who are willing to give their written informed consent and comply with the protocol requirements. 2. Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 3. Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study
Exclusion criteria
Exclusion criteria: 1.Subjects who have consumed ashwagandha containing food 2 days prior to screening 2. Subjects having symptoms of viral infection, including COVID-19 infection 3. Pregnant or lactating women. 4. Subjects with known hypersensitivity to the investigational products. 5. Subjects who have participated in any clinical trial in the past 1 month. 6. Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study. 7. Any other condition that in the opinion of the investigator that does not justify the subjectâ??s participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentrations of BAE20, 500 mg in comparison with normal unformulated Ashwagandha extract (UAE20) supplementation in plasma after oral administrationTimepoint: Day 1 (Period 1), Day 11 (Period 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety and tolerability of BAE20, 500 mg in comparison with normal unformulated Ashwagandha extract (UAE20) supplementationTimepoint: Day 1 (period 1), Day 11 (Period 2) | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed