A comparative Clinical study to evaluate the Bioavailability of BSW3510 with normal unformulated active ingredients.
- Registration Number
- CTRI/2019/08/020871
- Lead Sponsor
- Akay Flavours and Aromatics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1Subjects who are willing to give their written informed consent and comply with the protocol requirements.
2Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
3Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study
1Subjects who have consumed turmeric containing food 2 days prior to screening
2Pregnant or lactating women.
3Subjects with known hypersensitivity to the investigational products.
4Subjects who have participated in any clinical trial in the past 1 month.
5Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study.
6Any 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 Estimate the concentrations of BSW3510 in comparison with normal unformulated supplementationTimepoint: Day 0, Day 1, Day 11, Day 21, Day 31
- Secondary Outcome Measures
Name Time Method Maximum plasma concentrations (Cmax) of BSW3510 in comparison with normal unformulated supplementation <br/ ><br>Area under the plasma concentrations versus time curve (AUC) of BSW3510 in comparison with normal unformulated supplementation <br/ ><br> <br/ ><br>The safety and tolerability of BSW3510 in comparison with normal unformulated supplementationTimepoint: Day 0, Day 1, Day 11, Day 21, Day 31