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| Name | Class |
|---|---|
| Novonex Pharma Kft | INDUSTRY |
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The aim of this study is to evaluate the bioavailability of "Novo C Plus" vitamin C containing dietary supplement compared to licensed vitamin C medications. The novelty of this product is the liposomal formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 600 mg Novo C plus | Experimental | Single dose of oral 600 mg Novo C plus dietary supplement (contains 600 mg ascorbic acid in liposomal formulation) |
|
| 900 mg Novo C Plus | Experimental | Single dose of 900 mg oral Novo C plus dietary supplement (contains 900 mg ascorbic acid in liposomal formulation) |
|
| 500 mg intravenous vitamin C | Active Comparator | Single dose of 500 mg intravenous ascorbic acid (Vitamin C 100 mg/ml injection; EGIS) |
|
| 500 mg oral vitamin C | Active Comparator | Single dose of 500 mg oral ascorbic acid (Cetebe 500 mg retard capsules; GlaxoSmithKline Consumer Healthcare - GSK Export) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic Acid | Drug | Ascorbic acid in different ways and doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma ascorbic acid concentration area under curve | Plasma ascorbic acid concentration will be measured from peripheral blood samples after 30-45-60-90-120-180-240-300-360 minutes after getting the medication. Area under curve of time - plasma concentration curve will be calculated. | 360 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0 | 24 hours | |
| Urine ascorbic acid excretion | Urine is collected for 12 hours after taking study drug, and urine ascorbic acid excretion will be calculated: urine ascorbic acod concentration (uM)×collected urine (L). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University - 1st Departement of Internal Medicine | Budapest | 1083 | Hungary |
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| ID | Term |
|---|---|
| D001206 | Ascorbic Acid Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 12 hours |
| D009750 |
| Nutritional and Metabolic Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |