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.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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.
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
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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).
时间窗: Baseline,Day 1, Day 7, Day 13, Day 19, Day 25, Day 31
次要结局
- 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)
研究者
Jestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd