A Comparative, Single-Dose, 2-Way Crossover, 6 Sequence Study to Assess the Bioavailability of Formulated Caffeine (FC-AK-23) in Comparison with Normal Unformulated Caffeine (UFC-AK-23) and A Commercial Caffeine Supplementation (CC-AK-23) in Healthy Volunteers.
Overview
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Akay Natural Ingredients Pvt. Ltd
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- To estimate the concentrations of formulated caffeine (FC-AK-23) in comparison with normal unformulated caffeine (UFC-AK-23) and a commercial caffeine supplementation (CC-AK-23).
Overview
Brief Summary
This is a comparative single-dose, 2-way crossover, 6-sequence study to compare the bioavailability of formulated caffeine (FC-AK-23) in comparison with normal unformulated caffeine (UFC-AK-23) and a commercial caffeine supplementation (CC-AK-23). A group of 14 healthy volunteers willing to give written informed consent will be screened on Visit 1 to confirm their eligibility. Subjects fulfilling the eligibility criteria will be assigned to 1 of 6 treatments on Visit 2 followed by treatment sequences 2, 3, 4, 5, and 6 on subsequent visits (Visit 3, 4, 5, 6 & 7). There will be 5 washout periods in between the 5 doing days.
Study Design
- Study Type
- Ba/be
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Healthy non-smoking volunteers who are not involved in any regular medication or supplementation.
- •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.
- •Subject who understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
- •4.Subjects having body mass index (BMI) in between 19-26 kg/m2.
Exclusion Criteria
- •1.Subjects who have consumed caffeine supplements within 2 days prior to the screening 2.Subjects having symptoms of viral infection.
- •3.Pregnant or lactating women.
- •4.Subjects with known hypersensitivity to the investigational products (IP).
- •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 subject’s participation in the trial.
Outcomes
Primary Outcomes
To estimate the concentrations of formulated caffeine (FC-AK-23) in comparison with normal unformulated caffeine (UFC-AK-23) and a commercial caffeine supplementation (CC-AK-23).
Time Frame: Baseline,Day 1, Day 7, Day 13, Day 19, Day 25, Day 31
Secondary Outcomes
- Pharmacokinetic parameters of formulated caffeine (FC-AK-23) in comparison with unformulated (UFC-AK-23) and commercial caffeine supplementation (CC-AK-23).(Baseline,Day 1, Day 7, Day 13, Day 19, Day 25, Day 31)
- The safety & tolerability of FC-AK-23, UFC-AK-23 and CC-AK-23.(Baseline,Day 1, Day 7, Day 13, Day 19, Day 25, Day 31)
Investigators
Jestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd