Open label, randomised, one period one sequence, single dose, pharmacokinetic study to evaluate the bioavailability of Resveratrol and Pterostilbene after administration of single dose of NOVAGENERE-XAR and NOVAGENERE-XAP capsules in six healthy, adult, male human subjects under fasting conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To evaluate the pharmacokinetics of Resveratrol and Pterostilbene after administration of single dose of Novagenere-XAR and Novagenere-XAP Capsules
研究概览
简要总结
Resveratrol is a polyphenol that is abundant in grape skin andseeds. Food sources of resveratrol include wine,berries, and peanuts. This compound has many properties, including activityagainst glycation, oxidative stress,inflammation, neurodegeneration, several types of cancer, and aging. Becauseresveratrol is generallywell tolerated, it is believed to be a promising compound in preventing manydiseases, such as diabetes and itscomplications. Unfortunately, this compound exhibits low bioavailability andsolubility.
Pterostilbene is a phenoliccompound originally isolatedfrom the heartwoodof red sandalwood. Its presencein grape vines and blueberrieswas also reported later. Moreover,it was also produced in Pterocarpus marsupium, a tree whose wood is primarily used inthe treatment of diabetes by the Ayurvedicphysicians. Pterostilbene shares many chemical,physiological and pharmacological similarities with resveratrol, a dietary polyphenolic compound that has attracted extensiveinterests recently. Structurally, pterostilbene is a dimethylether analog of resveratrol. It is reported to have effects as cancer chemo-preventive anti-diabetic, and anti-ageing.
The aim of the study is to assess the bioavailability, safety, and efficacy of NOVAGENERE XAR and NOVAGENERE XAP in 6 healthy, adult, male human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •An age between 18 to 45 years (both inclusive), having body mass index (BMI) between 18.5 and 30 Kg/m2, weighing not less than 45 kg No symptoms of fever, headache, cold, cough, running nose etc.
- •which would indicate possible COVID infection.
- •No incidence of COVID amongst family members or neighborhood in preceding two weeks (of screening or site visit).
- •Not been admitted to hospital for COVID in preceding four weeks before the screening date.
- •A negative COVID – Antigen Test (horizontal Flow) at each site visit.
- •It may be followed by COVID-19 RT-PCR test (if needed) which also should be negative.
- •No medical history of significant diseases A physical examination, laboratory evaluations are clinically insignificant A negative or non-reactive Rapid Plasma Reagin (RPR), Hepatitis B Surface Antigen (HBsAg), Hepatitis C (Anti HCV), antibodies to human immune-deficiency Virus (HIV) I and II.
- •A negative breath alcohol test A negative urine test for drugs of abuse Normal clinical parameters on physical examination.
- •Vital signs examination that are within clinically acceptable limits No significant medical complaints No significant allergies especially for peanuts, grapes.
排除标准
- •Known hypersensitivity to grapes or resveraterol or peanuts or any inactive ingredients or related drugs.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
- •History or presence of significant alcoholism or drug abuse in the past one year.
- •History or presence of significant smoking and use of tobacco products.
- •History or presence of significant asthma, urticaria or other allergic reactions.
- •History or presence of significant gastric and/or duodenal ulceration.
- •History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •History or presence of cancer.
- •Presence of disease markers of HIV1 or 2, Hepatitis A, B viruses and syphilis.
- •Difficulty with donating blood.
- •Difficulty in swallowing solids like Lozenges or capsules.
- •Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. Pulse rate less than 60/minute or more than 100/minute.
- •Oral temperature less than 35oC or more than 37.5oC.
- •Respiratory rate less than 12/minute or more than 20/minute Use of any prescribed medication during last two weeks or OTC medicinal products and grapefruit juice and 48hrs prior to initiation of study.
- •Major illness during 3 months before screening.
- •Participation in a drug research study within past 3 months.
- •Donation of blood in the past 3 months before screening.
结局指标
主要结局
To evaluate the pharmacokinetics of Resveratrol and Pterostilbene after administration of single dose of Novagenere-XAR and Novagenere-XAP Capsules
时间窗: 0.50, 1.00, 2.00, 3.00, 6.00 hours following drug administration
次要结局
- To evaluate safety and tolerability of Novagenere-XAR and Novagenere-XAP Capsules(0.50, 1.00, 2.00, 3.00, 6.00 hours following drug administration)