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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Semmelweis University
• Collaborator: Novonex Pharma Kft
• Treatments: Ascorbic Acid; Vitamins

Criteria

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