None listed
Conditions
Interventions
Intervention1: AKOA1 Emulsion Formulation: 1000 mg
Oral administration
Single dose
Two period
Control Intervention1: ADHA 1: 500 mg
Oral administration
Single Dose
Two Period
Sponsors
Akeso Biopharma Pte. Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the relative bioavailability of AKOA1 Emulsion Formulation Containing 1000 mg DHA and ADHA1Timepoint: 18 time points -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
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability in healthy, adult, human subjects under Fed conditionsTimepoint: 18 time points -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 | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and Research Private Limited
Outcome results
None listed