To determine the quantity of omega-3 fatty acid available in healthy volunteers

Not Applicable

Completed

• Registration Number: CTRI/2024/04/065938
• Lead Sponsor: Akeso Biopharma Pte. Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-06-17
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Healthy adult human subjects of age between 18-45 years and 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

Subject is willing to abstain from consuming fish seafood omega-3 supplements or other dietary supplements or ALA-rich food within 20 days before randomization and throughout the study

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

Non Smokers

Generally healthy as documented by gynaecological examination and breast examination

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

If subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subject’s last study-related visit has a negative serum pregnancy test

Exclusion Criteria

Evidence of allergy or known hypersensitivity to Algal DHA Emulsion 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

Individual has TG greater than or equal to 150 mg/dL and/or LDL-C greater than or equal to 160 mg/dL and/or non-HDL-C greater than or equal to100 mg/dL at screening

Individual has consumed fish seafood omega-3 supplements or ALA-rich food within 20 days before randomization and throughout the study

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 48.00 hours prior to check-in and throughout the entire study

Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study

Subjects who have taken an unusual diet for whatever reason (e.g. low salt) for 48.00 hours prior to dosing and throughout the study

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

History of difficulty in swallowing accessibility of veins

Positive results for urine screen of drugs of abuse 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

Use of hormone replacement therapy for a Period of 06 months prior to dosing

Female subjects demonstrating a positive pregnancy screen who are currently lactating and who are likely to become pregnant during conduction of the study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
To assess the relative bioavailability of AKOA1 Emulsion Formulation Containing 1000 mg DHA and ADHA1Timepoint: 18 time points <br/ ><br>-12.00, 00.00, 01.00, 02.00, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 08.00, 10.00, 12.00, 18.00 and 24.00

Secondary Outcome Measures

Name	Time	Method
To monitor the safety and tolerability in healthy, adult, human subjects under Fed conditionsTimepoint: 18 time points <br/ ><br>-12.00, 00.00, 01.00, 02.00, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 08.00, 10.00, 12.00, 18.00 and 24.00