Linezolid in Healthy Volunteers
- Registration Number
- NCT03841721
- Lead Sponsor
- Prince of Songkla University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Age 20 - 40
- BMI 19 - 24 kg/m2
- normal CLcr
- normal liver function
- Subject who pregnant
- Subject who have documented hypersensitivity to linezolid
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description linezolid 300 mg Linezolid oral tablet 300 mg/day for 5 day -
- Primary Outcome Measures
Name Time Method Concentration of linezolid in plasma 24 hour after the linezolid dose Individual concentration of linezolid in plasma
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
🇹🇭Hat Yai, Songkla, Thailand