A study to assess the bio availability of BCO-5 in comparison with unformulated extracts in healthy volunteers.

Not Applicable

• Registration Number: CTRI/2022/11/047533
• 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: 9 January 2023

Recruitment & Eligibility

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

Inclusion Criteria

1.BMI between 18-25 kg/m2 (inclusive)

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 infections in the last 2 weeks

2.Pregnant or lactating women

3. History of Irritable bowel syndrome, malabsorption or gastrointestinal abnormalities which may affect drug absorption, duodenal ulcer or gastric ulcer, gastritis, Kidney disease, kidney stones, cardiac conditions, Recent blood donation (within 1 month),Current smoker or has quit smoking within last 3months, Alcoholism and/or drug abuse, or heavy drinkers, Immunodeficiency disease (e.g., human immunodeficiency virus infection,Allergy, medication or supplement use that influences the immune system

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Plasma Concentration With BCO-5,Unformulated Ingredient I, and Unformulated Ingredient II administrationsTimepoint: Day 1 (Period I) and Day 11 (Period II) and Day 21 (Period III)

Secondary Outcome Measures

Name	Time	Method
The safety and tolerability BCO-5 in comparison with unformulated ingredient I and unformulated ingredient II supplementationTimepoint: Day 1 (Period I), Day 11 (Period II) and Day 21 (Period III)