A Prospective, Single-Centre, Two-Arm, Interventional, Randomized, Double-Blind, Cross-Over Study to Evaluate and Compare the Pharmacokinetics of NAD+ and its Liposomal Formulation (LNAD+) in Healthy Adult Participants.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- NAD+ concentrations will be assessed by determining the following:
研究概览
简要总结
This study is designed to fill that void. Using a randomized, double-blind, crossover design, the trial will compare the pharmacokinetics of orally administered native NAD and its liposomal formulation LNAD in healthy adults. By measuring parameters across both formulations, the study aims to:
· Quantify systemic exposure of NAD from both formulations,
· Evaluate whether liposomal encapsulation significantly enhances oral bioavailability, and
· Determine interindividual variability in pharmacokinetic response.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male/female healthy participants aged 18 to 65 years;
- •Participants with Body Mass Index (BMI) between 18.5 and 24.99 kg/m2;
- •Participants who are willing to provide written Informed Consent for participating in the study;
- •Participants who are able to follow verbal and written study directions;
- •Participants willing to abstain from consumption of foods, medications, or dietary supplements containing the investigational drug (or related compounds) from 3 days prior the start of the study and throughout its duration.
排除标准
- •Participants with history of allergic reactions or hypersensitivity to the investigational drug or related supplements;
- •Participants having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator;
- •Participants with any acute illness diagnosed within 3 months before screening;
- •Participants with a medical history or active diagnosis of chronic diseases or conditions affecting the urinary, cardiovascular, neuroendocrine (including diabetes), immune, central nervous, hematopoietic, gastrointestinal, hepatic, or visual systems, hereditary diseases, or other significant systemic disorders, as well as those with acute infectious diseases within 28 days prior to the study, known allergies or positive test results for sexually transmitted infections such as HIV, hepatitis B, hepatitis C, or syphilis;
- •Female participants with positive result for urinary beta human chorionic gonadotropin or gestation period or breastfeeding;
- •Participants who smoked more than 2 cigarettes a day within 6 months before screening
- •Participants unwilling to refrain from high intensity physical activity for a minimum of 3 days before start of the study and throughout its duration.
- •8.Participants who have a history of recent injuries or is hospitalized within the past 3 months.
结局指标
主要结局
NAD+ concentrations will be assessed by determining the following:
时间窗: Time frame: 0h, 0.5h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, and 24.0h
· Whole blood concentration
时间窗: Time frame: 0h, 0.5h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, and 24.0h
· Plasma concentration
时间窗: Time frame: 0h, 0.5h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, and 24.0h
· Erythrocyte concentration
时间窗: Time frame: 0h, 0.5h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, and 24.0h
次要结局
- Pharmacokinetic parameters will be assessed by determining the following: · Peak Plasma Concentration (Cmax) · Time to peak drug concentration (Tmax), Area under curve (AUC) and half life(Time frame: 0h, 0.5h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 6.0h, 8.0h, 12.0h, and 24.0h)
研究者
Dr Chikkalingaiah Siddegowda
Medstar Speciality Hospital