None listed
Conditions
Interventions
Intervention1: Different Alpha Monolaurin Nutraceutical formulations: Granule, capsule and solution forms of Alpha Monolaurin Nutraceutical formulations will be compared agenst marketed comparator pro
Sponsors
DMTD Vit Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male volunteers of 18 to 45 years (both years inclusive) with BMI of 18.50â??29.99 Kg/m2. 2. Healthy volunteers as evaluated by medical history, vitals and general clinical examination. 3. Normal or clinically insignificant biochemical, hematological, urinary, serology, Chest X Ray and ECG values/ reports. 4. Generally healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments. 5. Subjects who have no evidence of medical illness during screening and check-in and whose screening is performed within 28 days of check in. 6. Negative urine test for drugs of abuse, alcohol breathe analysis. 7. Subject, who have no evidence of suspected Covid-19 symptoms
Exclusion criteria
Exclusion criteria: 1. History of any major surgical procedure in the past 3 months. 2. History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematological and/or any major surgical procedure in the past three months. 3. History of chronic alcoholism/chronic smoking/drug of abuse/ Hypersensitivity. 4. Subject who consumed tobacco containing products within 48 hours prior to proposed time of dosing 5. Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 7 days which potentially modify kinetics / dynamics of Monolaurin or any other medication judged to be clinically significant by the investigator. 6. Consumption of grapefruit and/or its products within 10 days prior to the start of study. 7. Subject who had participated in any other clinical study or who had bled during the last 90 days. 8. Subjects who are allergic to coconut/coconut containing foods or known hypersensitivity to Monolaurin/lauric acid or its derivatives 9. History of difficulty in swallowing. 10. High blood pressure and asthma 11. Renal or liver impairment 12. Subjects, who consumed raw coconut, coconut oil, coconut containing products, etc. in last 5 days will be excluded from the study. 13. History of past and present COVID-19 infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-tTimepoint: at -12.00 hrs, -06.00 hrs and within 60 minutes prior to dosing (00.00 hours). The post-dose blood samples (04 mL each) will be collected at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 04.00, 06.00, 12.00, 24.00 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, Kel, T1/2 and AUC0-ï?¥Timepoint: at -12.00 hrs, -06.00 hrs and within 60 minutes prior to dosing (00.00 hours). The post-dose blood samples (04 mL each) will be collected at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 04.00, 06.00, 12.00, 24.00 hours | — |
Countries
India
Contacts
Public ContactSathishkumar
Glocare Labs Pvt Ltd
Outcome results
None listed