Pharmacokinetic study of Standardized Ashwagandha (Withania somnifera) 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
- 1.Pharmacokinetics parameters like Cmax, Tmax, AUC0-t, AUC0-infinity, t1/2, Kel will be calculated from the concentration Vs. time data.
研究概览
简要总结
Herbal nutraceuticals and functional foods have gained worldwide popularity since last decade due to increasing awareness about health among consumers and a steady increase in life expectancy. Withania somnifera (Ashwagandha), also known as “Indian Winter Cherry†is a valuable herb used as “Rasayana†to promote a youthful state for physical and mental health for over 3000 years. Roots of Withania somnifera have been used to prepare a tonic that enhances longevity, revitalizes the body, arrests the aging process and augment a defense against dreadful diseases, such as cancer, Alzheimer’s and epilepsy. Withania species consist of chemical constituents from diverse chemical classes. Due to the complexity in the characterization of chemical constituents of such medicinal plants, establishing pharmacokinetics and pharmacodynamics (PK-PD) relationships remained a challenge. However, knowledge of pharmacokinetics (PK) of active ingredients after oral administration is always of a great interest for food / nutritional products containing Withania somnifera. That is why the proposed study is planned to be conducted to study pharmacokinetics of active ingredients (Withanosides and Withanolides) of Withania somnifera root extract.
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 investigational product Withania somnifera root extract is Ayurvedic Proprietary Medicine/nutraceutical product and hence is safe to administer healthy human subjects. Considering its safety, and considering the objective of interest as pharmacokinetics, the healthy human subjects are proposed as study population for this study.
The investigational product, capsule is formulated from the extract of Withania somnifera roots. The capsule containing single dose of 500 mg Standardized Withania somnifera root extract for oral administration, hence, the proposed route for this study is selected as oral administration. Single dose pharmacokinetics is sufficient at this stage of development; hence, the proposed study is planned as single dose pharmacokinetics study.
The present research is an attempt of exploration of pharmacokinetic profile along with the safety of the Standardized Ashwagandha (Withania somnifera) extract capsules in healthy human volunteers.
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
- Male
入选标准
- •1.Healthy male subject aged between 18 and 45 years (both inclusive).2.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.3.Subjects with a BMI between 18.50-30.00 kg/m2 and body mass, not less than 50.00 kg.4.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).5.Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording.6.Subjects having a normal or clinically not significant chest X-Ray (P/A view).7.A negative alcohol breath test result.8.Subject able to communicate effectively and provide written informed consent.
- •9.Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee.10.Subjects that can provide adequate evidence of their identity.11.Availability of volunteers for the entire study duration.12.Ability to fast for at least 14.00 hours and consume standard meals.
排除标准
- •1.Known hypersensitivity to Ashwagandha (Withania somnifera) or related drugs or any component of this medication.2.Incapable of understanding the informed consent information.3.History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric disease or disorder.4.Any treatment which could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study.5.History or presence of alcoholism or drug abuse.6.History or presence of asthma, urticaria, or other allergic reactions.
- •7.History or presence of gastric and/or duodenal ulceration.8.History or presence of thyroid disease, adrenal dysfunction, or organic intracranial lesion.9.History or presence of cancer.10.Difficulty with donating blood.11.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 prior to study initiation and throughout the study.12.Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study.13.Smokers who smoke 9 or more cigarettes/day or inability to abstain during the study.14.Subject consumed tobacco/tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study.15.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 prior to initiation of the study and throughout the study.16.Major illness during the 90 days before screening.17.Participation in a drug research study within 90 days of screening.
- •18.Donation of blood within 90 days of screening.
- •19.Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL.20.History or presence of easy bruising or bleeding.21.Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study.22.Male volunteer unwilling to employ appropriate contraceptive measures to ensure that his partner will not get pregnant during the study till 07 days after the completion of the study.23.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
1.Pharmacokinetics parameters like Cmax, Tmax, AUC0-t, AUC0-infinity, t1/2, Kel will be calculated from the concentration Vs. time data.
时间窗: PK blood samples will be collected at pre-dose [within 45 min prior to IP administration] and post dose at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 9.00, 12.00, and 24.00 hrs. (Total 13 Time points).
次要结局
- 1.Safety assessments will include screening, pre-dose and post-dose vital signs, clinical examination, ECGs, clinical laboratory testing (hematology, blood chemistry, chest x-ray and urinalysis), and reporting of AEs and SAEs.(2.Monitoring and recording of adverse events, serious adverse events during the study period throughout the study.)