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

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

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.

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