Linezolid in Healthy Volunteers
Pharmacokinetics/Pharmacodynamics of Oral Linezolid 300 mg/Day in Healthy Volunteers
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started May 2018
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 13, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 15, 2019
February 1, 2019
3 months
February 13, 2019
February 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concentration of linezolid in plasma
Individual concentration of linezolid in plasma
24 hour after the linezolid dose
Study Arms (1)
linezolid 300 mg
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Age 20 - 40
- BMI 19 - 24 kg/m2
- normal CLcr
- normal liver function
You may not qualify if:
- Subject who pregnant
- Subject who have documented hypersensitivity to linezolid
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110, Thailand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Medicine, Faculty of Medicine, Prince of Songkla University
Study Record Dates
First Submitted
February 13, 2019
First Posted
February 15, 2019
Study Start
May 1, 2018
Primary Completion
August 1, 2018
Study Completion
December 31, 2019
Last Updated
February 15, 2019
Record last verified: 2019-02