CTRI/2022/07/044061尚未招募未知
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
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 â?? 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.
- •History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension, glaucoma etc.
- •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.
研究者
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