NCT02723669

Relative Bioavailability of AR10 Compared to Reference Product

Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study to Determine the Relative Bioavailability of AR10 (Acetylcysteine Effervescent Tablets) Compared to Reference Product in Healthy, Adult Subjects, Fasting

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Arbor Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the relative bioavailability of Acetylcysteine Effervescent Tablets (AR10) and Reference N-acetylcysteine. Patients will receive both products in an Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover design.

Detailed description

An Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study Relative Bioavailability Study. The present study is intended to compare and evaluate the relative bioavailability of a single 11 gram dose of AR10 (acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g\]), and the reference Listed Drug (acetylcysteine solution; oral 20% \[200 mg/mL\] of American Pharmaceutical Partners) in healthy adult, human subjects under fasting conditions. A balanced block randomization schedule will be generated before the start of dosing.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AR10	effervescent tablet
DRUG	acetylcysteine	oral solution

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2016-03-30
• Last updated: 2016-03-30