Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 729 for:    Area Under Curve AND Bioavailability

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02606773
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
Novonex Pharma Kft
Information provided by (Responsible Party):
Istvan Takacs, Semmelweis University

Brief 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.

Condition or disease Intervention/treatment Phase
Vitamin C Deficiency Drug: Ascorbic Acid Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Randomized Comparator Study for Evaluation the Bioavailability of "Novo C Plus" Vitamin C Containing Dietary Supplement in Healthy Subjects
Study Start Date : June 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Experimental: 600 mg Novo C plus
Single dose of oral 600 mg Novo C plus dietary supplement (contains 600 mg ascorbic acid in liposomal formulation)
Drug: Ascorbic Acid
Ascorbic acid in different ways and doses

Experimental: 900 mg Novo C Plus
Single dose of 900 mg oral Novo C plus dietary supplement (contains 900 mg ascorbic acid in liposomal formulation)
Drug: Ascorbic Acid
Ascorbic acid in different ways and doses

Active Comparator: 500 mg intravenous vitamin C
Single dose of 500 mg intravenous ascorbic acid (Vitamin C 100 mg/ml injection; EGIS)
Drug: Ascorbic Acid
Ascorbic acid in different ways and doses

Active Comparator: 500 mg oral vitamin C
Single dose of 500 mg oral ascorbic acid (Cetebe 500 mg retard capsules; GlaxoSmithKline Consumer Healthcare - GSK Export)
Drug: Ascorbic Acid
Ascorbic acid in different ways and doses




Primary Outcome Measures :
  1. Plasma ascorbic acid concentration area under curve [ Time Frame: 360 minutes ]
    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.


Secondary Outcome Measures :
  1. Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 24 hours ]
  2. Urine ascorbic acid excretion [ Time Frame: 12 hours ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606773


Locations
Layout table for location information
Hungary
Semmelweis University - 1st Departement of Internal Medicine
Budapest, Hungary, 1083
Sponsors and Collaborators
Semmelweis University
Novonex Pharma Kft

Layout table for additonal information
Responsible Party: Istvan Takacs, Reader in university, Semmelweis University
ClinicalTrials.gov Identifier: NCT02606773     History of Changes
Other Study ID Numbers: NVP-14C
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Istvan Takacs, Semmelweis University:
vitamin C supplementation
Additional relevant MeSH terms:
Layout table for MeSH terms
Scurvy
Ascorbic Acid Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents