Pharmacokinetics
Conditions
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.
Interventions
DRUGAscor L 500® (Ascorbic Acid Injection, USP)
A sterile, solution containing 500 mg ascorbic acid per mL
Sponsors
McGuff Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of Ascorbic Acid (µM) in plasma | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed