To study the bioavailability of omega-3 syrup
- Registration Number
- CTRI/2019/03/018209
- Lead Sponsor
- Arjuna Natural Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
1.Healthy male volunteers within 18-45 years of age (both inclusive) who have given voluntary consent and screened within 21 days prior to the first dosing day.
2.Body Mass Index (BMI) in the range 18.5-30 kg/m2 and weighing at least 50 kg.
3.Normal health as determined by medical history and physical examination, ECG, Chest X-Ray and laboratory tests performed within 21 days prior to the commencement of the study.
4.Screening laboratory values within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
1.Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, laboratory evaluations, ECG, & chest X-ray recording]
2.A depot injection or implant of any drug within 3 months prior to administration of study medication.
3.Intake of any investigational drug within 4 months, any allopathic drugs or herbal supplements (OTC/Prescription) containing omega-3, including any enzyme modifying drugs within the last 14 days prior to the to the initial dose of study drug.
4.Donated blood (1 unit or 450 mL) within 90 days prior to the initial dose of the study drug or have blood loss, excluding volume drawn at screening for this study, (<=100 mL within 30 days; <=200 mL within 60 days; >200 mL within 90 days) prior to initial dose of study drug, whichever is greater.
5.Presence or history of significant gastrointestinal, liver or kidney disease, or any conditions (like history of difficulty in swallowing) known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
6.History of allergic responses to omega-3, fish oil or related products containing omega-3 or any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Co-Investigator, could contraindicate the volunteerâ??s participation in this study.
7.Active peptic ulceration or a history of peptic ulceration.
8.Resting hypotension (BP <90/60) or hypertension (BP > 139 /89).
9.Pulse rate below 50/ min. and above 99/min.
10.History of clinically significant, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
11.History of Myocardial Infarction, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage.
12.Those who have been hospitalized within the last 4 weeks preceding the start of the study.
13.A History of drug abuse or alcoholism (greater than 7 drinks/ week)
14.Smoker or have stopped smoking in < 1 yr.
15.Difficulty with donating blood or intolerance to venipuncture.
16.A positive Breath Alcohol Analysis or Urine Drug Screen (UDS) before admission.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the oral bioavailability of omega-3 from fish oil syrup in 16 healthy adult human subjects under fasting conditions.Timepoint: Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 24 hours post dose
- Secondary Outcome Measures
Name Time Method To monitor the safety of the subjects.Timepoint: Vitals at time of admission, prior to dosing (0 Hours) and at 1, 2, 4, 6, 8, 12 hours post-dose and at the time of checkout (24 Hours); Laboratory assessment at the end of the study