CompletedNCT02534753Updated Mar 23, 2016

A Pharmacokinetics Study of Intravenous Ascorbic Acid

A Phase 1 interventional study of Ascor L 500® (Ascorbic Acid Injection, USP) in Pharmacokinetics, sponsored by McGuff Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-23.

Sponsored by McGuff Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 8
Allocation: Not applicable
Ages: 18 Years to 45 Years
Sex: All

Study summary

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

Read the detailed description

The objectives of this study are:

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

Conditions studied

Pharmacokinetics

In context

Lead sponsor

This is the only study on the registry with McGuff Pharmaceuticals, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts 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

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

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 8 participants (actual)

Study arms

Experimental
Single Group
Drug: Ascor L 500® (Ascorbic Acid Injection, USP)

Interventions

DrugAscor L 500® (Ascorbic Acid Injection, USP)
A sterile, solution containing 500 mg ascorbic acid per mL
Also known as: Ascorbic Acid

What researchers measure

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

Study locations

1 site

Virginia Commonwealth University
Richmond, Virginia 23284, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02534753
Lead sponsor: McGuff Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Aug 28, 2015
Start date: Sep 2015
Primary completion: Nov 2015
Completion: Jan 2016
Last update: Mar 23, 2016

Study contacts

Damon P Jones, BS/MBA

study director · McGuff Pharmaceuticals, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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