A Pharmacokinetics Study of Intravenous Ascorbic Acid

McGuff Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Ascor L 500® (Ascorbic Acid Injection, USP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02534753

MGP-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Single Group

Experimental group

Treatment:

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