Linezolid in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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linezolid 300 mg

Group Type EXPERIMENTAL

Linezolid oral tablet 300 mg/day for 5 day

Intervention Type DRUG

Linezolid oral tablet 300 mg/day for 5 day and blood sample were obtained by direct venipuncture at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hour after drug administration in day 5

Interventions

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Linezolid oral tablet 300 mg/day for 5 day

Linezolid oral tablet 300 mg/day for 5 day and blood sample were obtained by direct venipuncture at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hour after drug administration in day 5

Intervention Type DRUG