Clinical Pharmacokinetic Study of Standardized Crocus sativus Extract Capsules in Healthy Human Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study will be to calculate
研究概览
简要总结
Crocus sativus L., also known as saffron, is a popular food condiment with a high aroma, deep color, and long and thick threads (stigmas). Saffron is cultivated in many countries, including India (Kashmir saffron), Spain (Spanish saffron), Iran (Persian saffron), Afghanistan, France, Morocco, and Greece. It is popular folklore and Indian traditional medicine used in the treatment of various health conditions such as eye health, skin disorders, digestive ailments, women’s health, and others In recent studies, Crocus sativus was found to have prominent action against neurodegenerative disorders, namely Alzheimer’s (AD), Parkinson’s disease, dementia, and anxiety, due to the presence of bioactive constituents’ carotenoids (Crocin, Crocetin) and apocarotenoids (Picrocrocin, Safranal), etc. The growing number of clinical trials involving saffron extract for various therapeutic uses such as age-related macular degeneration, anxiety, mood disorder, and so on, as well as the growing interest in phytomedicine, emphasize the importance of conducting pharmacokinetic studies for saffron and its bioactive phytoconstituents.
Thus, single dose phamacokinetic study of standerdized Crocus sativus extract in human provide crucial data on its absorption, distribution, metabolism, and elimination. This knowledge can contribute to the development of safer and more effective dosing strategies, aid in understanding the therapeutic potential of Crocus sativus, and support evidence-based decision-making regarding its clinical use.
The investigational product capsules (10 mg) is formulated from standerdized Crocus sativus stigma extract. The single dose 20 mg (2*10 mg capsules in sequence) will be administred to healthy subjects.
Single dose pharmacokinetics is sufficient at this stage of development; hence, the proposed study is planned. Subject’s disease condition, liver function, kidney function etc. greatly affect pharmacokinetics of any active ingredients; hence, healthy human subjects are always considered the best population to study pharmacokinetics of any active ingredients of such products.
The present research is an attempt of exploration of the pharmacokinetic profile along with safety and tolerability of standardized Crocus sativusextract capsule and its constituents after acute oral administration in healthy, adult human subjects under fasting conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female human subject aged between 18 and 45 years (both inclusive); 2.Female subject must have a negative urine pregnancy test prior to the housing; 3.Females of childbearing potential agreeing to use appropriate contraceptive measures like non hormonal intrauterine device, barrier methods, spermicidal agents during the study and 07 days after completion of the study; 4.Male agreeing to use appropriate contraceptive measures like the Double Barrier method (Condom), and should not donate sperm, etc.
- •during the study and 07 days after completion of the study; 5.Subjects with a BMI between 18.50-30.00 kg/m2 and body mass, not less than 50.00 kg; 6.Subjects in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests); 7.Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording; 8.Subjects having a normal or clinically not significant chest X-ray (PA view); 9.A negative alcohol breath test result; 10.Subject able to communicate effectively and provide written informed consent; 11.Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee; 12.Subjects that can provide adequate evidence of their identity; 13.Availability of volunteers for the entire study duration; 14.Ability to fast for at least 14.00 hours and consume standard meals.
排除标准
- •Known hypersensitivity to saffron (Crocus sativus) 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, 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/day or inability to abstain during the study;
- •Subject consumed tobacco/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;
- •Subject 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;
- •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.
- •Total hysterectomy and an absence of bleeding for at least 3 months.
- •Female volunteers who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing;
- •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.
结局指标
主要结局
The primary endpoint of the study will be to calculate
时间窗: Pharmacokinetic blood samples will be collected at pre-dose [within 45 min before IP administration] & post-dose at 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360, 720, 1440 min. (Total 17 Time points).
1. Plasma pharmacokinetic parameters: Cmax, AUC0-t, AUC0-infinity, Tmax, Kel, t1/2, etc. from concentration Vs. time data.
时间窗: Pharmacokinetic blood samples will be collected at pre-dose [within 45 min before IP administration] & post-dose at 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360, 720, 1440 min. (Total 17 Time points).
次要结局
- The tolerability & safety of the intervention will be assessed by evaluating:(1.Screening, pre-dose, and post-dose vital signs.)