A Pharmacokinetics Study of Intravenous Ascorbic Acid

McGuff Pharmaceuticals, Inc.8 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pharmacokinetics

Interventions

Ascor L 500® (Ascorbic Acid Injection, USP)DRUG

A sterile, solution containing 500 mg ascorbic acid per mL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Concentration of Ascorbic Acid (µM) in plasma

Time frame: 1 day

Secondary Outcomes

Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) grouped by body system

Time frame: 1 day

Changes from Baseline in clinical laboratory and vital signs to discharge

Time frame: 1 day

Changes from pre-dose physical exam findings to discharge

Time frame: 1 day

Data from ClinicalTrials.gov

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