None listed
Conditions
Interventions
Intervention1: Omega 3 Fish oil capsules
(with advanced technolog)
: After an overnight fasting of at least 10.00 hours, a
single dose of Omega 3 Fish oil capsules – (300mg of EPA ethyl ester and 200
Sponsors
Amway Global Services India Pvt Ltd
In Vitro Research Solution Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers who accept for participating in this study must: 1. Healthy, adult male, subjects aged between 18-45 years (both inclusive) at the time of screening. 2. Having a Body Mass Index (BMI) between 18.50 to 24.99 kg/m2 (both inclusive) at the time of screening. 3. Normal or clinically insignificant findings during screening, medical history, clinical examination including vital signs, laboratory evaluations, 12 lead ECG and X-ray chest (posterior-anterior view) recordings. 4. Able to comply with the study procedures, in the opinion of the principal investigator. 5. Compliance with study specific restrictions and prohibitions. 6. Able to give voluntary written informed consent for participation in the trial. 7. Complying to avoid fish the previous day as well as for the entire study period
Exclusion criteria
Exclusion criteria: If any subject is having any of the following conditions, then exclude him from participation in this study: 1. Known hypersensitivity or idiosyncratic reaction to the study Investigational product or any related Product. 2. Regular user of supplements containing Omega-3 fatty acid 3. History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system. 4. Ingestion of any medicine at any time within 14 days prior to IP administration in period I. In any such case subject selection will be at the discretion of the principal investigator. 5. Habit of consuming high caffeine (more than 5 cups of coffee or tea/day). 6. Smokers and Alcoholics. 7. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in 8. An unusual or abnormal diet within 48.00 hours prior to study check-in, whatever reason e.g. because of fasting due to religious reasons. 9. People consuming fish in their diet 7 days prior to the study. 10. The presence of clinically significant abnormal laboratory values during screening. 11. Use of any recreational Products or history of Product addiction or testing positive in pre-study urine drug screening and Urine alcohol test. 12. A history of difficulty with donating blood or having donated blood in the preceding 90 days for males prior to the start of the study. 13.Subject who has participated in any other clinical study involving Investigational product administration and collection of blood samples in the 90 days for males preceding the start of the study. 14.Difficulty in swallowing capsule. 15. Positive HIV, VDRL/RPR, Hepatitis B and C tests. 16. Subjects who have used any Products or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC(0-t) and AUC(0-inf)Timepoint: From baseline to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, Kel, t½ and AUCExtrapolated%Timepoint: From baseline to end of study | — |
Countries
India
Contacts
Public ContactDr Anilkumar B H
Notrox Research Pvt. Ltd.
Outcome results
None listed