Study to Establish the Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract in Humans
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Maximal concentration level of Devil's Claw metabolites, Cmax (ng/ml)
研究概览
简要总结
Study will define the bioavailability and short term pharmacokinetics of the principal secondary metabolites of a aqueous-ethanolic extract of H. procumbens in non-enteric and enteric capsules.
详细描述
The study(n = 12) will use a one-dose design to measure bioavailability and pharmacokinetic properties of an aqueous extract of H. procumbens containing 100mg harpagoside. Plasma levels of harpagoside, harpagide, verbascoside, and 8-p-coumarylharpagide will be measured for 24 hours with blood collections taken at timed intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (at least 18 years of age);
- •diagnosed with knee osteoarthritis (OA) ;
- •body mass index (BMI) of less than 40;
- •willing to use only the study product, and Tramadol or Tylenol as a rescue pain medication over the course of their participation in the study;
- •willing and able to monitor blood glucose levels if diabetic;
- •willing to abstain from caffeine-containing drinks and food before coming into a study visit;
- •able to read and understand English and have the cognitive capacity to give consent;
- •willing to abstain from use of the following during participation in the study: prescription and over-the-counter non-steroidal anti-inflammatory medications, (e.g., aspirin, ibuprofen, Advil, Motrin, Nuprin, Naproxen, etc.); any dietary supplements (St. John's Wort, etc.); and, grapefruit and/or products containing it.
排除标准
- •cardiovascular disease, previous myocardial infarction, stent, coronary artery bypass graft (CABG), arrhythmia, high or low blood pressure;
- •recurrent stomach upset, or gastric or duodenal ulcers;
- •gallstones or gall bladder disease (cholelithiasis);
- •liver or kidney disease;
- •alcohol use of more than two drinks per day on a regular basis;
- •Coumadin or anti-platelet drug use;
- •at risk for respiratory depression, history of seizures, or taking drugs that reduce the seizure threshold or may increase the risk for development of serotonin syndrome;
- •pregnant or breast feeding, or intention to become pregnant during the study;
- •pronounced allergies, or known allergy to study product or corn starch (placebo);
- •have had an injection to treat OA within the past three months;
- •currently taking NSAIDs, unless they are willing to stop for a 1-week wash-out period;
- •currently on a selective serotonin reuptake inhibitor (SSRI) but are poorly stabilized, or have evidence of suicidal ideation and/or suicide attempts in the past year; and,
- •reported use during the 7 days prior to study drug administration of: prescription and over-the-counter medications (e.g., NSAIDs), and any dietary supplements; grapefruit and/or its products; and, St. John's Wort.
研究组 & 干预措施
Enteric coated Devil's Claw
H. procumbens 100 mg in enteric coated capsules
干预措施: Enteric coated Devil's Claw (Drug)
Non-enteric coated Devil's Claw
H. procumbens 100 mg in non-enteric coated capsules
干预措施: Non-enteric coated Devil's Claw (Drug)
结局指标
主要结局
Maximal concentration level of Devil's Claw metabolites, Cmax (ng/ml)
时间窗: 0.5 hour, 1 hour, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 12 hours
Blood will be drawn at predefined intervals following administration of one dose of study drug
Time to reach Cmax (h)
时间窗: 0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours
Blood will be drawn at predefined intervals following administration of one dose of study drug
Determination of terminal half-life of Devil's Claw, t 1/2 (h)
时间窗: 0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours
Blood will be drawn at predefined intervals following administration of one dose of study drug
次要结局
- Change in plasma levels of harpagide(24 hours after dose of Devil's Claw)
- Change in levels of 8-p-coumarylharpagide(24 hours after dose of Devil's Claw)
- Change in plasma levels of verbascoside(24 hours after dose of Devil's Claw)
- Change in plasma levels of harpagoside(24 hours after dose of Devil's Claw)
研究者
William Folk
Professor
University of Missouri-Columbia