A Pharmacokinetics Study of Intravenous Ascorbic Acid

A Phase 1, Single-Dose Study to Evaluate the Pharmacokinetics of Intravenous Ascorbic Acid in Healthy Male and Female Volunteers

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.

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.