To assess the bioavailability, safety, and efficacy of Resveratrol and Pterostilbene in NOVAGENERE XAR and NOVAGENERE XAP
- Registration Number
- CTRI/2022/07/044061
- Lead Sponsor
- Epigeneres Biotech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method