Healthy
Conditions
Keywords
pharmacokinetic, linezolid, healthy volunteers
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.
Interventions
DRUGLinezolid 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
Sponsors
Prince of Songkla University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of linezolid in plasma | 24 hour after the linezolid dose | Individual concentration of linezolid in plasma |
Countries
Thailand
Outcome results
None listed