CTRI/2025/02/081268
Not yet recruiting
Not Applicable
A Randomized, Double-Blind, 3-Way Crossover, 3 Sequence Study to Assess the Bioavailability of Formulated Boswellia-PEA (FBQP-AK-24) in Comparison with Normal Unformulated Boswellia-PEA (UFBQP-AK-24) Supplementation in Healthy Volunteers
Akay Natural Ingredients Pvt. Ltd1 site in 1 country15 target enrollmentStarted: March 10, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Akay Natural Ingredients Pvt. Ltd
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- To estimate the concentrations of formulated Boswellia-PEA (FBQP-AK-24) in comparison with normal unformulated Boswellia-PEA (UFBQP-AK-24) supplementation
Overview
Brief Summary
This is a comparative, randomized, 3-way crossover, 3-sequence study to compare the bioavailability of formulated Boswellia-PEA (FBQP-AK-24) in comparison with normal unformulated Boswellia-PEA (UFBQP-AK-24) supplementation. A group of 15 healthy volunteers willing to give a written informed consent will be screened on Visit 1 to confirm the eligibility. Subjects fulfilling the eligibility criteria will be randomized into 1 of 3-treatment sequences on Visit 2, followed by treatment sequences 2 and 3 on subsequent visits (Visit 3 and 4). There will be 2 washout periods in betweeen the 3 dosing days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 2.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study
- •Subjects having body mass index (BMI) in between 19-26 kg/m2.
Exclusion Criteria
- •1.Subjects who have consumed either Boswellia or PEA containing food/supplement 7 days prior to screening 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
- •Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.
Outcomes
Primary Outcomes
To estimate the concentrations of formulated Boswellia-PEA (FBQP-AK-24) in comparison with normal unformulated Boswellia-PEA (UFBQP-AK-24) supplementation
Time Frame: Baseline, Day 9, Day 17
Secondary Outcomes
- Safety and tolerability of FBQP-AK-24 in comparison with UFBQP-AK-24 supplementation.(Baseline, Day 9, Day 17)
- Pharmacokinetics parameters of FBQP-AK-24 in comparison with UFBQP-AK-24 supplementation(Baseline, Day 9, Day 17)
Investigators
Jestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Study Sites (1)
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