None listed
Conditions
Interventions
Intervention1: NOVAGENERE-XAR and NOVAGENERE-XAP: Single-arm, Single-dose, oral Administration of NOVAGENERE-XAR and NOVAGENERE-XAP
Control Intervention1: NA: NA
Sponsors
Epigeneres Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics of Resveratrol and Pterostilbene after administration of single dose of Novagenere-XAR and Novagenere-XAP CapsulesTimepoint: 0.50, 1.00, 2.00, 3.00, 6.00 hours following drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety and tolerability of Novagenere-XAR and Novagenere-XAP CapsulesTimepoint: 0.50, 1.00, 2.00, 3.00, 6.00 hours following drug administration | — |
Countries
India
Contacts
Public ContactDr Sasikumar Menon
Institute for Advanced Training and Research in Interdisciplinary Sciences
Outcome results
None listed