To check the oral bioavailability study of Omega-3-fatty acid

Not Applicable

• Registration Number: CTRI/2022/09/045892
• Lead Sponsor: Dr M Ganesan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Normal healthy adult human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2

Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in

Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance

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 system) and vital sign assessments

Generally healthy as documented by 12-lead electrocardiogram (ECG), Chest X-Ray and clinical laboratory assessments

Willing to consume ovo lacto-vegetarian diet

Willing to comply to all requirements of this study protocol as well as instructed by the study personnel

Generally healthy as documented by gynaecological examination and breast examination (for female subjects â?? period I only)

Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period

Exclusion Criteria

Evidence of allergy or known hypersensitivity to Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA) and Quercetin or its supplements

Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus and pre-existing gallbladder disease

Any major illness in the last three months or any significant ongoing chronic medical illness

Subjects will be instructed to avoid consumption of fish and fish oil from 03 weeks prior to the dosing

Renal or liver impairment

Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, Or any other body system, presence of Diabetes Mellitus and Psychosis

History of alcohol addiction or abuse

Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate and caffeine-containing sodas, colas, etc.), cigarettes and tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study

Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study and any over the counter medicinal products, herbal medications within 07 days prior to study check-in and throughout the study

Subject who had participated in any other study within the 90 days of check-in

History of difficulty in swallowing

History of difficulty in accessibility of veins

Positive results for urine screen of drugs of abuse (Marijuana-THC, amphetamine-AMP, barbiturates-BAR, cocaine-COC, benzodiazepines-BZD and morphine-MOR) in urine prior to check-in of this study period

Positive results for alcohol test prior to check-in of each period

Any blood donation / excess blood loss within 90 days of check-in

Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in

Female subjects demonstrating a positive pregnancy screen

Female subjects who are currently lactating

Study & Design

• Study Type: BA/BE
• Study Design: Not specified