Linezolid in Healthy Volunteers

Prince of Songkla University

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Linezolid oral tablet 300 mg/day for 5 day

Study type: Interventional

Funder types: Other

Identifiers

NCT03841721

Linezolid 61087141

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 20 - 40
• BMI 19 - 24 kg/m2
• normal CLcr
• normal liver function

Exclusion criteria

• Subject who pregnant
• Subject who have documented hypersensitivity to linezolid

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

linezolid 300 mg

Experimental group

Treatment:

Drug: Linezolid oral tablet 300 mg/day for 5 day