Clinical Trial to Investigate the Pharmacokinetics of Second-Line Anti-Tuberculosis Agents

Phase 1 Completed 16 enrolled Seoul National University Hospital

RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to investigate the pharmacokinetic characteristics of second-line anti-tuberculosis agents after oral/intramuscular administration in healthy male volunteers.

Timeline

Start: 2013-11
Primary completion: 2013-12
Completion: 2014-01

Publications

Park SI, Oh J, Jang K, Yoon J, Moon SJ, Park JS, Lee JH, Song J, Jang IJ, Yu KS, Chung JY. Pharmacokinetics of Second-Line Antituberculosis Drugs after Multiple Administrations in Healthy Volunteers. Antimicrob Agents Chemother. 2015 Aug;59(8):4429-35. doi: 10.1128/AAC.00354-15. Epub 2015 May 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aminosalicylic acid	Unknown	5.28 g	—
Subject	Cycloserine	Small molecule	250 mg	—
Subject	Kanamycin	Small molecule	1 g	Intramuscular
Subject	Levofloxacin	Small molecule	750 mg	—
Subject	Moxifloxacin	Small molecule	400 mg	—
Subject	Protionamide	Small molecule	250 mg	—
Subject	Pyrazinamide	Small molecule	1500 mg	—
Subject	streptomycin	Other / unclassified	1 g	Intramuscular

Indications

No indication recorded.