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NCT03841721 Clinical Trial

Linezolid in Healthy Volunteers

Healthy Clinical Trial

Official title:
Pharmacokinetics/Pharmacodynamics of Oral Linezolid 300 mg/Day in Healthy Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03841721
Other study ID # Linezolid 61087141
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date May 1, 2018
Est. completion date December 31, 2019

Study information
Verified date February 2019
Source Prince of Songkla University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date December 31, 2019
Est. primary completion date August 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
Thailand Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University Hat Yai Songkla

Sponsors (1)
Lead Sponsor Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concentration of linezolid in plasma Individual concentration of linezolid in plasma 24 hour after the linezolid dose
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