None listed
Conditions
Interventions
Intervention1: Vytals Fish Oil SMEDs Softgel Capsule (Each 1 g softgel contain 338mg EPA and 225mg DHA): As per randomizaion a single dose (4 softgel capsules) of intervention product will be adminis
Sponsors
Vytals Wellbeing India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject s age should be between 18 to 50 years (both inclusive). 2. Subjects who are able to read and write the vernacular language (English and Hindi) and understand the study requirements. 3. Must have provided written informed consent for participation in the study in the subject s vernacular language (English and Hindi). 4. Minimum weight 50.0 kg. 5. BMI 18.50 to 29.50 Kg per m2 (both inclusive). 6. Healthy as determined by medical history, physical, clinical and laboratory examination performed within 28 days prior to admission for the first period of the study. 7. In the opinion of the Principal Investigator or Co Investigator or designee, be able to comply with the study procedures and protocol restrictions.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity (include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria) or idiosyncratic reaction to (omega 3 fatty acid) or any substituted benzimidazole and its excipients or similar classes of drugs. 2. Any evidence of significant abnormalities upon physical or clinical examination. 3. Laboratory values, which are significantly different from pre defined reference ranges and judged clinically significant. 4. Consumption of grapefruit juice grapefruit at least 48 hours prior to admission in all period of the study. 5. Clinical symptoms of Cyanocobalamin (Vitamin B 12) Deficiency 6. Any clinically significant abnormality in Chest X Ray PA view or invalid Chest X ray PA view (after 01 year of validity). 7. Any clinically significant abnormality in ECG. 8. Regular use of tobacco or nicotine in significant amount in any form (e.g. use of equal to or more than 5 cigarettes a day) or have difficulty in abstaining from (smoking) nicotine use for the entire duration of the study. 9. History of drug dependence or excessive alcohol intake on a habitual basis, or, inability to abstain from alcohol for the entire duration of study. 10. History or presence of significant gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological, hematologic, or endocrine disease. 11. History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension, glaucoma etc. 12. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses and syphilis. 13. Positive result for drug(s) of abuse testing (amphetamines, barbiturates, benzodiazepines, tetrahydrocannabinol, morphine, and cocaine) in urine 14. Positive for urine alcohol. 15. History or presence of any psychiatric illness including Symptoms of Depression or mania (Sleep Disturbances, Interest pleasure reduction, Guilt feelings or thoughts of worthlessness, energy changes fatigue, concentration attention impairment, appetite weight changes, psychomotor disturbances and having thoughts of suicide) and or intake of any anti-depressant medications. 16. History or presence of any allergic illness including allergic skin diseases, allergic asthma and drug-induced allergy, e.g., NSAIDs. 17. History of intake administration of any investigational treatment in a clinical study within last 90 days prior to the onset of the study admission of period I of the study 18. History of significant blood loss (more than 350 mL) due to any reason, including blood donation within last 90 days prior to admission of period I of the study. 19. Existence of any surgical or medical condition which in the judgement of principal investigator designee might interfere with the absorption, distribution, metabolism or elimination of the study drug, or, is likely to compromise the safety of subject. 20. Intake or administration of any enzyme modifying drugs such as cimetidine, ampicillin, antihistamines, within 30 days of Period I admission. In such cases, subject selection will be at the discretion of the Principal Investigator or medical officer. 21. Intake or administration of drugs which mentioned below have interaction with Omega 3 fatty acid within last 30 days of Period I admission. In such cases, subject selection will be at the discretion of the Principal Investigator or medical office
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the bioavailability, to characterize the pharmacokinetic profile of the Test Product (T) [Vytals Fish Oil SMEDs Softgel Capsule (Each 1 g softgel contain 338mg EPA and 225mg DHA) of Alder Biochem Private Limited, India] with Reference Product (R) [Plain Fish Oil Softgel Capsule (Each 750mg softgel capsule contain 338mg EPA and 225mg DHA) of Alder Biochem Private Limited, India]Timepoint: Subjects will visit at study site at period I and period II with the 07 days wash out period and each period Samples will be collected at Pre-dose (0.00) and 0.50, 1.00, 2.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00, 16.00, 18.00 and 24.00 hours post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the study subjects will also be monitored and evaluated.Timepoint: Sitting blood pressure, pulse rate, respiratory rate, and body surface temperature will be recorded at check-in and before check-out in each period. Measurements of blood pressure, pulse rate, and body surface temperature will be taken in sitting/supine position at pre-dose (0:00), and at 3, 5, 6, 8, 12, and 24 hours ( 40 minutes) post-dose. AE/SAE monitoring will be conducted throughout the study. | — |
Countries
India
Contacts
Public ContactMr Manoj Karwa
Vytals Wellbeing India Private Limited
Outcome results
None listed