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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To estimate the concentrations of formulated Boswellia-PEA (FBQP-AK-24) in comparison with normal unformulated Boswellia-PEA (UFBQP-AK-24) supplementation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To estimate the concentrations of formulated Boswellia-PEA (FBQP-AK-24) in comparison with normal unformulated Boswellia-PEA (UFBQP-AK-24) supplementation
时间窗: Baseline, Day 9, Day 17
次要结局
- 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)
研究者
Jestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd