Novo C Plus Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Open-label, Randomized Comparator Study for Evaluation the Bioavailability of Novo C Plus Vitamin C Containing Dietary Supplement in Healthy Subjects

Conditions
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Vitamin C Deficiency

Intervention / Treatment
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* Drug: Ascorbic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21-65 years old healthy volunteers body weight >45 kg body height >150 cm plasma ascorbic acid at screening <75 µmol/l signed written informed consent subject agrees avoid vitamin C containing medications and dietary supplements from screening until V0 visit (maximum 15 days) subject agrees to avoid high activity physical exercise 72 hours prior to V0 visit Exclusion Criteria: confirmed or suspected active infection liver or renal failure (equal or greater than CKD3) chronic disease that affects absorption or vitamin C metabolism severe metabolic disorder body mass index >35 kg/m2 malabsorption syndrome that affects vitamin C metabolism heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with >100/min ventricular rate gastrointestinal bleeding in past three months uncontrolled diabetes mellitus (HbA1c>8,5%) malignant disease alcohol or drug abuse active psychiatric disorder, intention for suicidal, disorders with unconsciousness psychopathic disorder, lack of cooperation known coagulopathy chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months) untreated hypertension if blood pressure is greater than 165/95 mmHg gravidity or breastfeeding taking more than 100 mg vitamin C daily within 2 weeks to screening

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 600 mg Novo C plus<br>Single dose of oral 600 mg Novo C plus dietary supplement (contains 600 mg ascorbic acid in liposomal formulation) | Drug: Ascorbic Acid<br>* Ascorbic acid in different ways and doses<br>|
| Experimental: 900 mg Novo C Plus<br>Single dose of 900 mg oral Novo C plus dietary supplement (contains 900 mg ascorbic acid in liposomal formulation) | Drug: Ascorbic Acid<br>* Ascorbic acid in different ways and doses<br>|
| Active Comparator: 500 mg intravenous vitamin C<br>Single dose of 500 mg intravenous ascorbic acid (Vitamin C 100 mg/ml injection; EGIS) | Drug: Ascorbic Acid<br>* Ascorbic acid in different ways and doses<br>|
| Active Comparator: 500 mg oral vitamin C<br>Single dose of 500 mg oral ascorbic acid (Cetebe 500 mg retard capsules; GlaxoSmithKline Consumer Healthcare - GSK Export) | Drug: Ascorbic Acid<br>* Ascorbic acid in different ways and doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin C supplementation