Healthy Clinical Trial - Linezolid in Healthy Volunteers

Status Active, not recruiting

Clinical Trial Summary

Linezolid is the first synthetic antibiotic of oxazolidinone group that can inhibit bacterial protein synthesis. Previous studies have found that linezolid was an effective treatment for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB). In addition, the current dosage recommendation (1,200 mg/day) occasionally resulted in serious adverse events including bone marrow suppression and peripheral neuropathy.

The objective study were determine the pharmacokinetics of oral linezolid 300 mg /day in healthy volunteers. This study conducted in six healthy volunteers. All subject received an oral linezolid 300 mg/day by directly observed treatment (DOT) at the same time each day for 5 days. Blood samples were collected on day 5 at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h post dosing. The separated plasma samples were evaluated by ultra-performance liquid chromatography (UPLC). All pharmacokinetic parameters were calculated.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT03841721
Study type	Interventional
Source	Prince of Songkla University
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	May 1, 2018
Completion date	December 31, 2019

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