Relative Bioavailability of Two Different Milk Thistle Formulations: A Single Dose Randomized Crossover Pharmacokinetic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of Product B® IsaGenesis® versus IsaGenesis®
研究概览
简要总结
This is a single dose, randomized, cross-over pharmacokinetic study in healthy volunteers (n=12) of two dietary supplement formulations. The Product B® IsaGenesis® formulation represents a newer reformulation of an existing product known simply as IsaGenesis®. Beyond some changes in the relative abundance of some of the constituents of the earlier IsaGenesis® formulation, the Product B® IsaGenesis® product has been formulated as a liquid-gel formulation (rather than a dried powder extract) which is theorized to enhance the absorption and bioavailability of the contained botanical constituents. The purpose of this study is to compare the two dietary supplement formulations relative to the absorption of two compounds contained within the supplement known as the flavonolignans silybin A and silybin B into the bloodstream after oral administration of capsules.
详细描述
The study involves a total of five (5) visits to the University of Florida Shands CRC located in the Clinical Translational Research Building in Gainesville, and is expected to last approximately 6 weeks.
Screening / Informed Consent:
The Screening Visit will be conducted in the CRC and is expected to last approximately 1 hour.
After obtaining written Informed Consent, study subjects will be interviewed about their medical history and the protocol's Inclusion/Exclusion criteria will be discussed. All potential participants must be nonsmokers, not taking prescription or over-the-counter medications or botanical/nutritional supplements (inclusive of vitamins). Additionally, participants are requested to abstain from alcohol use 24 hours prior to the study health screen lab work or any scheduled study visit should they participate fully in the study.
During this initial visit, interested subjects will have blood samples drawn for health screening purposes including baseline serum chemistries, complete blood count, urinalysis, and a urine pregnancy test (women) which will precede a subsequently scheduled physical exam and possible study participation. Copies of the laboratory results will be made available to study subjects at their request. Lastly, a 12-lead electrocardiogram will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent
- •Race or ethnicity: no restrictions
- •Body Mass Index (BMI) between 18.5 to 28 kg/m2 (inclusive)
- •Satisfactory completion of the screening medical history, physical exam, and laboratory evaluations.
- •Females of child-bearing potential must have a negative urine pregnancy test prior to enrollment and avoid pregnancy during study participation.
- •With the exception of oral contraceptives, subjects must not be taking prescription or over the counter medication for the duration of study participation
- •Subjects must have no ongoing use of any botanical/nutritional supplement, vitamin, or energy drink for the duration of study participation
排除标准
- •The presence of a known allergy to ragweed and related plants from the Asteraceae/Compositae plant family. Members of this family include ragweed, chrysanthemums, marigolds, daisies, and some others. Milk thistle may cause an allergic reaction in people who are sensitive to these plants.
- •A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurologic disease will render subjects ineligible for the study.
- •The presence of any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion including;
- •Gastric bezoar
- •Swallowing disorders
- •Strictures
- •GI obstruction
- •Severe dysphagia
- •Crohn's disease
- •Diverticulitis
- •A positive urine pregnancy test.
- •Any concomitant prescription medication, over-the-counter medication, herbal or other supplements, and vitamins during the study period.
研究组 & 干预措施
Product B® IsaGenesis®, Then IsaGenesis®
Participants will come into the clinic in a fasting state to receive the Product B® IsaGenesis®, which will be a one time dose of the liquid-gel formulation contained in 2 capsules, 1280 mg per capsule. After a washout period of 7 days, they will then come back to the clinic in a fasting state to receive the IsaGenesis®. This will be given for a comparison in a one time dose of the dried powder extract contained in 2 capsules; 1070 mg per capsule.
干预措施: Product B® IsaGenesis® (Dietary Supplement)
Product B® IsaGenesis®, Then IsaGenesis®
Participants will come into the clinic in a fasting state to receive the Product B® IsaGenesis®, which will be a one time dose of the liquid-gel formulation contained in 2 capsules, 1280 mg per capsule. After a washout period of 7 days, they will then come back to the clinic in a fasting state to receive the IsaGenesis®. This will be given for a comparison in a one time dose of the dried powder extract contained in 2 capsules; 1070 mg per capsule.
干预措施: IsaGenesis® (Dietary Supplement)
IsaGenesis®, Then Product B® IsaGenesis®
Participants will come into the clinic in a fasting state to receive the IsaGenesis®, which will be a one time dose of the dried powder extract contained in 2 capsules; 1070 mg per capsule. After a washout period of 7 days, they will then come back to the clinic in a fasting state to receive the Product B® IsaGenesis®. This will be given for a comparison in a one time dose of the liquid-gel formulation contained in 2 capsules; 1280 mg/capsule.
干预措施: Product B® IsaGenesis® (Dietary Supplement)
IsaGenesis®, Then Product B® IsaGenesis®
Participants will come into the clinic in a fasting state to receive the IsaGenesis®, which will be a one time dose of the dried powder extract contained in 2 capsules; 1070 mg per capsule. After a washout period of 7 days, they will then come back to the clinic in a fasting state to receive the Product B® IsaGenesis®. This will be given for a comparison in a one time dose of the liquid-gel formulation contained in 2 capsules; 1280 mg/capsule.
干预措施: IsaGenesis® (Dietary Supplement)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of Product B® IsaGenesis® versus IsaGenesis®
时间窗: 0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose
Peak Plasma Concentration (Cmax) of Product B® Isagenesis® versus IsaGenesis®
时间窗: 0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose
次要结局
- Number of Participants With Response to Product B® Isagenesis® versus IsaGenesis®(6 weeks)