Clinical Pharmacokinetic Study of Quercetin Extracts in Healthy Human Volunteers.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Tilman SA
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Plasma pharmacokinetic parameters
研究概览
简要总结
Despite the development and utilization of quercetin formulations in clinical settings, challenges persist due to its low bioavailability and limited absorption. Current research predominantly focuses on the nonclinical stage, with limited clinical investigations. The absorption and metabolic mechanisms of quercetin in the human body remain unclear. To enhance its application in preventing and treating clinical diseases, there is a pressing need for in-depth pharmacokinetic studies to unravel the pharmacological mechanisms of quercetin.
Formulating an effective bioavailability strategy and undertaking a thorough pharmacokinetic investigation of Quercetin will be crucial for optimizing its therapeutic use by understanding its absorption, distribution, metabolism, and excretion. This study provides essential information on bioavailability, dosage determination, administration frequency, duration of action, tissue distribution, metabolism, and safety. Knowledge of metabolic pathways and elimination routes helps identify potential drug interactions, ensuring safe elimination without toxicity or accumulation.
Investigation of Quercetin’s pharmacokinetic profile will also contribute to understanding its safety and tolerability, including potential drug interactions and adverse effects. In pharmacokinetic investigations, selecting healthy human subjects is essential for accurate assessment of the active ingredient’s dynamics. It is imperative to include both males and females to detect potential gender-related variations in absorption, distribution, metabolism, and excretion processes. Hence, the goal of this study is to determine the pharmacokinetic profile, bioavailability of quercetin, a poor soluble compound, under formulations B, C and D compared to the formulation A in healthy human volunteers following acute oral administration under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female human trial participants aged between 18 and 45 years (both inclusive);
- •Female trial participants must have a negative urine pregnancy test prior to the housing
- •Male and females agreeing to use the contraceptive pill or abstinence as a method of contraception during and 07 days after completion of the study;
- •Trial participants with a BMI between 18.50-28.00 kg per m2 and body mass, not less than 50.00 kg;
- •Trial participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests);
- •Trial participants having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording;
- •Trial participants having a normal or clinically not significant chest X-ray (PA view);
- •A negative alcohol breath test result;
- •Trial participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee;
- •Trial participants that can provide adequate evidence of their identity;
- •Availability of volunteers for the entire study duration;
- •Ability to fast for at least 14.00 hours and consume standard meals.
排除标准
- •Known hypersensitivity to Quercetin or related product or any component of this intervention;
- •Incapable of understanding the informed consent information;
- •Clinically significant medical condition, such as, but not limited to, cardiovascular, neurological, psychiatric, pulmonary, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease), or uncontrolled haematological abnormalities;
- •Any treatment which could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study;
- •History or presence of alcoholism or drug abuse;
- •History or presence of asthma, urticaria, or other allergic reactions;
- •History or presence of gastric and or duodenal ulceration;
- •History or presence of thyroid disease, adrenal dysfunction, or organic intracranial lesion;
- •History or presence of cancer;
- •Difficulty with donating blood;
- •Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week before study initiation and throughout the study;
- •Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study;
- •Smokers who smoke 9 or more cigarettes per day or inability to abstain during the study;
- •Trial participant consumed tobacco or tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours before initiation of the study and throughout the study;
- •Trial participant consumed caffeine and or xanthine-containing foods or beverages (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and grapefruit juice and poppy-containing foods for at least 48.00 hours before initiation of the study and throughout the study;
- •Major illness during the 90 days before screening;
- •Donation of blood within 90 days of screening;
- •Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL;
- •History or presence of easy bruising or bleeding;
- •Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study;
- •Females of childbearing potential with any one of the following reported and documented on the medical history: i.
- •Postmenopausal with spontaneous amenorrhea for at least one year, or ii.
- •Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii.
- •Pregnant women and nursing mothers;
- •Male and females of childbearing potential unwilling to employ appropriate and reliable method of contraception during the study till 07 days after the completion of the study;
- •Male volunteers willing to donate sperm during the study till 07 days after the completion of the study.
- •Consumption of dietary supplements likely to provide polyphenols and Quercetine.
结局指标
主要结局
Plasma pharmacokinetic parameters
时间窗: Pharmacokinetic blood samples will be collected at pre-dose [within 45 min before IP administration] and post-dose at 1h; 2h; 4h; 6h; 8h; 10h; and 24h. (Total 08 Time points).
次要结局
- The tolerability and safety of the intervention will be assessed by evaluating:(1.Screening, pre-dose, and post-dose vital signs.)
研究者
Dr V G Vaidya
Lokmanya Medical Research Centre