Optimal individual administration of linezolid and tedizolid using saliva concentrations to avoid blood sampling A single oral and intravenous dose of linezolid and tedizolid in healthy adult males (investigator-initiated clinical study)
- Conditions
- Healthy adult males
- Registration Number
- JPRN-UMIN000046556
- Lead Sponsor
- niversity of Toyama
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 12
Not provided
1) History of drug allergy 2) Hypersensitivity to the investigational drug 3) Participated in other clinical trials within the previous 2 weeks 4) Received drugs or supplements within the previous 3 days 5) Whole blood donor of 200 mL within the previous one month, blood component (platelets and plasma) donor within the previous 2 weeks, or Whole blood donor of 300 mL within the previous 3 months 6) 7) With childbearing potential and rejecting contraceptive methods during 1 week from the initial administration of the investigational drug 8) With abnormal findings on the medical examination within six months 9) Salivary gland disorder or oral disease 10) Liver or renal disease 11) Deemed inappropriate (for miscellaneous reasons) based on the assessment of either the principal investigator or the sub-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total and unbound LZD concentrations in saliva or serum up to 10 hours after oral or intravenous LZD administration Total and unbound TZD concentrations in saliva or serum up to 10 hours after oral or intravenous TZD administration
- Secondary Outcome Measures
Name Time Method