A Pharmacokinetics Study of Intravenous Ascorbic Acid
Phase 1
Completed
- Conditions
- Pharmacokinetics
- Interventions
- Registration Number
- NCT02534753
- Lead Sponsor
- McGuff Pharmaceuticals, Inc.
- Brief Summary
This is a Phase 1, single-dose study to evaluate the pharmacokinetics of intravenous Ascorbic Acid.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Group Ascor L 500® (Ascorbic Acid Injection, USP) -
- Primary Outcome Measures
Name Time Method Concentration of Ascorbic Acid (µM) in plasma 1 day
- Secondary Outcome Measures
Name Time Method Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) grouped by body system 1 day Changes from Baseline in clinical laboratory and vital signs to discharge 1 day Changes from pre-dose physical exam findings to discharge 1 day
Trial Locations
- Locations (1)
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University🇺🇸Richmond, Virginia, United States