Phase 1a: A Randomized, 2-period Cross-over Study to Compare the Bioavailability of Gamma-Delta Tocotrienol (GDT) With That of Tocotrienol Rich Fraction (TRF) in Twelve Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)of drug
研究概览
简要总结
Twelve healthy volunteers who fit the inclusion and exclusion criteria and provide written informed consent to participate in the trial will be recruited to compare the rate and extent of absorption and pharmacokinetics of the newly formulated Gamma-Delta formulation with TRF.
详细描述
Twelve healthy subjects will be admitted to a clinical study ward on the Day 0. Physical check up and the health status will be confirmed during check in. After fasting for a minimum of 10 hours overnight, each subject will be administered a single dose of TRF or Gamma-Delta after taking a standardized high-fat meal breakfast on Day 1. Thereafter, standard meals will be provided at 4 and 12 hours after dosing. Blood samples (5mL will be taken using an in-dwelling canula placed in the antecubital vein immediately before and at 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, and 24 hours after dosing. Subjects will be admitted for 24 hours and discharged after the last blood sampling. During the study, blood pressure and the heart rate will be monitored regularly for safety profile.
After a one week wash out period, subject will return to the ward and be given the other formulation (TRF or GDT) and the same procedures will be repeated. Any adverse events that arise during the treatment will be recorded and followed up till resolution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female aged 21-55 years old
- •Good health
- •No allergy to vitamin E/ palm oil
- •No past (within 3 months) / current use of dietary supplements containing vitamin E
排除标准
- •History of bleeding tendencies or any condition predisposing to bleeding e.g. thrombocytopenia, abnormal liver function, liver disease (e.g. chronic hepatitis), gastrointestinal ulcers
- •Candidate for surgery or had undergone surgery in the past 6 months
- •Current or past use (last 3 months) of antithrombotic drugs such as antiplatelets (aspirin, ticlopidine), anticoagulants (heparin, warfarin), thrombolytic agents (streptokinase), etc
- •Current or past history of cancer
- •Pregnant/ breastfeeding women
- •Drug or alcohol abuse
- •Hypercholesterolemia
- •Chronic conditions such as uncontrolled hypertension, heart disease (ischemic heart disease, heart failure, cardiac arrhythmia), uncontrolled diabetes, HIV infection, or other psychiatric illness/ social situations that might limit adherence to study protocol.
- •Unable or unwilling to stop taking vitamins, herbal preparations or nonprescription medications
研究组 & 干预措施
Gamma-Delta Tocotrienol
干预措施: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction (Dietary Supplement)
TRF
干预措施: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction (Dietary Supplement)
结局指标
主要结局
Peak Plasma Concentration (Cmax)of drug
时间窗: 0 to 24 hours after dosing
次要结局
未报告次要终点
研究者
Puvaneswari Meganathan
Ms
Malaysia Palm Oil Board