Healthy adult males
Conditions
Interventions
Six healthy male subjects receive LZD 600 mg or TZD 200 mg intravenously and orally after 1 week. Pharmacokinetic saliva and blood sampling were performed for 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5,
Sponsors
University of Toyama
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy adult males 2) aged 20-50 years 3) BMI 18.5 kg/m2 or larger but less than 30.0 kg/m2 4) Provide informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHitoshi Kawasuji
Toyama University Graduate School of Medicine and Pharmaceutical Sciences Department of Clinical Infectious Diseases
Outcome results
None listed