CTRI/2022/11/047533
Not yet recruiting
未知
A randomized,single-dose,double-blind,3 way,3-sequence,crossover,study to assess the bioavailabilty of BCO-5 in comparison with unformulated extracts in healthy volunteers.
Akay Natural Ingredients Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Akay Natural Ingredients Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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