None listed
Conditions
Interventions
Intervention1: Narpega Oral Liquid: Narpega Oral Liquid
Oral Dose
2 times (each period once)
Control Intervention1: LOVAZA: LOVAZA® 4 X 1 GRAM CAPSULE
Oral Dose
2 times (each period one capsule)
Sponsors
Dr M Ganesan
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioavailability of NARPEGA ORAL LIQUID 40 mL (each 10 ml contains at least 900 mg of ethyl esters of omega-3 fatty acids and quercetin 14 mg) of KMS Health Center Pvt Ltd and LOVAZA® 4 x 1 GRAM CAPSULE (each 1 gm capsule contains at least 900 mg of the ethyl esters of omega-3 fatty acids) of GlaxoSmithKline (Woodward Pharma) along with 1 Capsule of QUERCETIN CAPSULE 56 mg of KMS Health Center Pvt Ltd in healthy adult human subjects under fed conditionsTimepoint: 23 -24.00, -12.00, -06.00, -01.00, 00.00, 00.50, 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, 24.00, 36.00 and 48.00 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability in healthy, adult, human subjects under fed conditionsTimepoint: 23 -24.00, -12.00, -06.00, -01.00, 00.00, 00.50, 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, 24.00, 36.00 and 48.00 hours | — |
Countries
India
Contacts
Public ContactDr Annamalai K
Spinos Lifescience and Research Private Limited
Outcome results
None listed