Trial | NCT02606773  Report issue

Title

"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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin c ...

  • Study Participants

    32
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.
Study Started
Jun 30
2015
Primary Completion
Sep 30
2015
Study Completion
Sep 30
2015
Last Update
Nov 17
2015
Estimate

Drug Ascorbic Acid

Ascorbic acid in different ways and doses

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)

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
No Results Posted