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| Name | Class |
|---|---|
| JW Pharmaceutical | INDUSTRY |
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Fish oil is a rich source of omega-3 fatty acids, especially eicosapentanoic acid and docosahexaenoic acid, and it is not used widely in parenteral nutrition because fish oil emulsions have not been commercially available until very recently. The Objective of this study is to to evaluate the effect on blood lipid profiles of omega-3 enriched total parenteral nutrition in healthy Korean male subjects. This study is designed as a randomized, open-label, 2-treatment, 2-way crossover trial. Blood samples will be collected every 1 hour from 0 to 12 hours after starting an intravenous infusion for triglyceride, glucose, and insulin.
Fish oil is a rich source of omega-3 fatty acids, especially eicosapentanoic acid and docosahexaenoic acid, and it is not used widely in parenteral nutrition because fish oil emulsions have not been commercially available until very recently. The Objective of this study is to to evaluate the effect on blood lipid profiles of omega-3 enriched total parenteral nutrition in healthy Korean male subjects.
This study is designed as a randomized, open-label, 2-treatment, 2-way crossover trial. The 16 subjects will be randomly assigned to 1 of 2 sequences of the two treatments: Combiflex® lipid peri or Winuf® peri will be infused via peripheral venous catheter for 6 hours at 3 ml/kg/h. Blood samples will be collected every 1 hour from 0 to 12 hours after starting an intravenous infusion for triglyceride, glucose, and insulin. Cholesterol, HDL-cholesterol, LDL-cholesterol, AST, ALT, and total bilirubin as liver function biomarkers, and hsCRP as inflammatory biomarker will be analysed at 0, 6 and 12 hour after starting an intravenous infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Combiflex® lipid peri as a reference product (Period 1) -> Winuf® peri as a test product (Period 2) |
|
| Group 2 | Experimental | Winuf® peri as a test product (Period 1) -> Combiflex® lipid peri as a reference product (Period 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combiflex® lipid peri | Drug | total parenteral nutrition solutions containing glucose, amino acids, electrolyte, soybean oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare AUC of plasma triglyceride between Winuf peri and Combiflex lipid peri | The wash-out period will be 7 days, and the second study period will be conducted on the same schedule as the first study period, with the exception of the assignment of the investigational product. | Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing |
| To compare Cmax of plasma triglyceride between Winuf peri and Combiflex lipid peri | The wash-out period will be 7 days, and the second study period will be conducted on the same schedule as the first study period, with the exception of the assignment of the investigational product. | Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| To compare AUC of plasma glucose between Winuf peri and Combiflex lipid peri | Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing | |
| To compare Cmax of plasma glucose between Winuf peri and Combiflex lipid peri | Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee Chul Yu, MD, PhD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 561712 | South Korea |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Winuf® peri | Drug | total parenteral nutrition solution containing glucose, amino acids, electrolyte, soybean oil, medium chain triglyceride, olive oil and fish oil |
|
| To compare AUC of plasma insulin between Winuf peri and Combiflex lipid peri | Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing |
| To compare Cmax of plasma insulin between Winuf peri and Combiflex lipid peri | Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing |
| To compare AUC of plasma omega-3 between Winuf peri and Combiflex lipid peri | Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing |
| To compare Cmax of plasma omega-3 between Winuf peri and Combiflex lipid peri | Before-dosing(0 hour) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing |
| Change from baseline in blood cholesterol level at 6 and 12 hours | Before-dosing(0 hour) and 6, and 12 hours |
| Change from baseline in blood HDL-cholesterol level at 6 and 12 hours | Before-dosing(0 hour) and 6, and 12 hours |
| Change from baseline in blood LDL-cholesterol level at 6 and 12 hours | Before-dosing(0 hour) and 6, and 12 hours |
| Change from baseline in blood AST level at 6 and 12 hours | Before-dosing(0 hour) and 6, and 12 hours |
| Change from baseline in blood ALT level at 6 and 12 hours | Before-dosing(0 hour) and 6, and 12 hours |
| Change from baseline in blood total bilirubin level at 6 and 12 hours | Before-dosing(0 hour) and 6, and 12 hours |
| Change from baseline in blood hsCRP level at 6 and 12 hours | Before-dosing(0 hour) and 6, and 12 hours |