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A Pharmacokinetics Study of Intravenous Ascorbic Acid

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ClinicalTrials.gov Identifier: NCT02534753
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
McGuff Pharmaceuticals, Inc.

Brief Summary:
This is a Phase 1, single-dose study to evaluate the pharmacokinetics of intravenous Ascorbic Acid.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: Ascor L 500® (Ascorbic Acid Injection, USP) Phase 1

Detailed Description:

The objectives of this study are:

  1. To evaluate the single-dose pharmacokinetics of AA administered intravenously (IV).
  2. To evaluate the safety and tolerability of AA administered intravenously.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-Dose Study to Evaluate the Pharmacokinetics of Intravenous Ascorbic Acid in Healthy Male and Female Volunteers
Study Start Date : September 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: Single Group Drug: Ascor L 500® (Ascorbic Acid Injection, USP)
A sterile, solution containing 500 mg ascorbic acid per mL
Other Name: Ascorbic Acid




Primary Outcome Measures :
  1. Concentration of Ascorbic Acid (µM) in plasma [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) grouped by body system [ Time Frame: 1 day ]
  2. Changes from Baseline in clinical laboratory and vital signs to discharge [ Time Frame: 1 day ]
  3. Changes from pre-dose physical exam findings to discharge [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is between the ages of 18 and 45 years, inclusive.
  • Has a body mass index (BMI) between 18 and 32 kg/m2.
  • Of sound health and has the ability to understand the requirements of the study and is willing to comply with all study requirements and procedures.

Exclusion Criteria:

  • Participates in activities that would not allow accurate evaluation of the pharmacokinetics of Ascorbic Acid
  • Medical or physical conditions that would not allow safe participation and/or accurate evaluation of the pharmacokinetics of Ascorbic Acid
  • Has participated in an investigational drug study within the 30 days prior to CRU admission.

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): NCT02534753


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
McGuff Pharmaceuticals, Inc.
Investigators
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Study Director: Damon P Jones, BS/MBA McGuff Pharmaceuticals, Inc.

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Responsible Party: McGuff Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02534753     History of Changes
Other Study ID Numbers: MGP-101
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances