A comparative Bioavailability study in Healthy Subjects
- Registration Number
- CTRI/2022/05/042653
- Lead Sponsor
- Vidya Herbs Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy volunteers who are not involved in any regular medication or supplementation.
2.Subjects who are willing to give their written informed consent and comply with the protocol requirements.
3.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
4.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study
1.Subjects who have consumed curcumin (turmeric) 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 into 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 Plasma concentrations of BDMC and curcuminTimepoint: Pre-dose sample within 1 hour before dosing. <br/ ><br>Post-dose samples will be collected at 30 min, 60 min, 90 min, 2, 4, 6 and 12.00 (hr:min)
- Secondary Outcome Measures
Name Time Method (Cmax), (tmax), (t1/2) ,(Kel)]Timepoint: Pre-dose sample within 1 hour before dosing. <br/ ><br>Post-dose samples will be collected at 30 min, 60 min, 90 min, 2, 4, 6 and 12.00 (hr:min)