Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid Phosphate

Phase 1 Completed 12 enrolled Merck & Co., Inc.

RandomizedCrossoverOpen-labelBasic science

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult subjects and to assess the relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule.

Timeline

Start: 2009-02
Primary completion: 2009-03
Completion: 2009-03

Publications

Flanagan SD, Bien PA, Munoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014 Mar;34(3):240-50. doi: 10.1002/phar.1337. Epub 2013 Aug 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tedizolid Phosphate	Small molecule	182 mg	Oral
Subject	Tedizolid Phosphate	Small molecule	200 mg	Oral

Indications

No indication recorded.