| CTRI Number |
CTRI/2024/04/065938 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To determine the quantity of omega-3 fatty acid available in healthy volunteers |
Scientific Title of Study
Modification(s)
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Period Two Sequence Two Way Crossover Comparative Bioavailability Study of AKOA1 Emulsion Formulation Containing 1000 mg DHA Manufactured by Bioplus Lifesciences Pvt Ltd India for Akeso Biopharma Pte Ltd Singapore and ADHA1 Manufactured by Bioplus Life Sciences India Pvt Ltd India In Healthy Adult Human Subjects Under Fed Conditions |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-CT-0001-24-OMEG Version 01 Date 11 Mar 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Clinical Trial Division
29 A Krishna Maduravanam Vellakinar Pirivu G N Mills Post Coimbatore
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Clinical Trial Division
29 A Krishna Maduravanam Vellakinar Pirivu G N Mills Post Coimbatore
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Clinical Trial Division
29 A Krishna Maduravanam Vellakinar Pirivu G N Mills Post Coimbatore
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Akeso Biopharma Pte Ltd
143 Cecil Street
No 25-03 G B Building
Singapore 069542 |
|
|
Primary Sponsor
|
| Name |
Akeso Biopharma Pte. Ltd |
| Address |
143 Cecil Street,
No 25-03 G B Building
Singapore 069542
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep T |
Spinos Lifescience and Research Private Limited |
Clinical Trial Division
Room 01
29 A Krishna Maduravanam
G N Mills Post Vellakinar Pirivu
Coimbatore
TAMIL NADU |
8220586899
pradeep.t@spinoslifescience.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Research Ethics Committee |
Approved |
| Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fed |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
ADHA 1 |
500 mg
Oral administration
Single Dose
Two Period |
| Intervention |
AKOA1 Emulsion Formulation |
1000 mg
Oral administration
Single dose
Two period
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess the relative bioavailability of AKOA1 Emulsion Formulation Containing 1000 mg DHA and ADHA1 |
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 Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability in healthy, adult, human subjects under Fed conditions |
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 |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/04/2024 |
| Date of Study Completion (India) |
17/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will commence only after a written approval is obtained from the Ethics Committee. The study will be conducted as per the National Ethical Guidelines for Biomedical and Health Research involving Human participants ICMR (2017), ICH E6 (R3) (Step 2) ’Guidance on Good Clinical Practice’, New Drugs and Clinical Trials Rules 2019 [Gazette notification G.S.R.227 (E), Dated 19.03.2019], India & its Third Amendment Rules [Dated 14th October, 2022], ’Good Laboratory Practice’, ‘Good Clinical Practices for Clinical Research in India’ Guidelines, Good Clinical Laboratory Practice (GCLP), Declaration of Helsinki (Fortaleza, October 2013) and USFDA (United States Food and Drug Administration) regulatory requirements. |