Relative Bioavailability of AR10 Compared to Reference Product

Phase 1 Completed 30 enrolled Arbor Pharmaceuticals, Inc.

RandomizedCrossoverOpen-label

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.

Timeline

Start: 2014-04
Primary completion: 2014-05
Completion: 2014-05

Publications

Greene SC, Noonan PK, Sanabria C, Peacock WF. Effervescent N-Acetylcysteine Tablets versus Oral Solution N-Acetylcysteine in Fasting Healthy Adults: An Open-Label, Randomized, Single-Dose, Crossover, Relative Bioavailability Study. Curr Ther Res Clin Exp. 2016 Jun 27;83:1-7. doi: 10.1016/j.curtheres.2016.06.001. eCollection 2016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	N-acetylcysteine	Small molecule	11 g	Oral

Indications

No indication recorded.