None listed
Conditions
Interventions
Intervention1: FF-20: Single day Oral Administration of Single dose of FF-20
Control Intervention1: unformulated active ingredient (UF): Single day Oral Administration of Single dose of unformulated a
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 having symptoms of viral infection, including COVID-19 infection 2. Pregnant or lactating women. 3. Subjects with known hypersensitivity to the investigational products. 4. Subjects who have participated in any clinical trial in the past 1 month. 5. Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study. 6. 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 |
|---|---|
| The primary objective of the study is to assess the bioavailability of FF-20 in comparison with normal unformulated active ingredient supplementation (UF).Timepoint: Day 1 (period 1), Day 11 (Period 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of the study is to assess the safety of FF-20 in comparison with normal unformulated active ingredient supplementation (UF). Timepoint: 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