None listed
Conditions
Interventions
Intervention1: FBQP-AK-24: 250 mg capsule,single-dose oral administration of FBQP-AK-24 for a duration of one day.
Intervention2: FBQP-AK-24: 500 mg capsule,single-dose oral administration of FBQP-AK-
Sponsors
Akay Natural Ingredients Pvt. Ltd
Eligibility
Inclusion criteria
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 3. Subjects having body mass index (BMI) in between 19-26 kg/m2.
Exclusion criteria
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 6. Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the concentrations of formulated Boswellia-PEA (FBQP-AK-24) in comparison with normal unformulated Boswellia-PEA (UFBQP-AK-24) supplementationTimepoint: Baseline, Day 9, Day 17 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters of FBQP-AK-24 in comparison with UFBQP-AK-24 supplementationTimepoint: Baseline, Day 9, Day 17;Safety and tolerability of FBQP-AK-24 in comparison with UFBQP-AK-24 supplementation.Timepoint: Baseline, Day 9, Day 17 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed