A comparative Bioavailability study of FF-20 in Healthy Volunteers

Not Applicable

• Registration Number: CTRI/2020/07/026748
• Lead Sponsor: Akay Natural Ingredients Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to assess the bioavailability of FF-20 in comparison with <br/ ><br>normal unformulated active ingredient supplementation (UF).Timepoint: Day 1 (period 1), Day 11 (Period 2)

Secondary Outcome Measures

Name	Time	Method
The secondary objective of the study is to assess the safety of FF-20 in comparison with <br/ ><br>normal unformulated active ingredient supplementation (UF). <br/ ><br>Timepoint: Day 1 (period 1), Day 11 (Period 2)