Pharmacokinetics(PK) study of Peramivir in Epithelial Lining Fluid (ELF), an open-label study.

Not Applicable

• Conditions: healthy volunteer

• Registration Number: JPRN-UMIN000007758
• Lead Sponsor: Keio University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-14
• Study Completion: 2015-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

1)History of hypersensitivity caused by lidocaine hydrochloride. 2)History of hypersensitivity caused by neuraminidase inhibitors. 3)In medication. 4)Creatinine clearance >=30mL/min. 5)Smorker. 6)Hepatic or Renal disorder, Anemia proved by the pre-medical test. 7)Any other participants whose condition is inappropriate for the evaluation of this clinical study, judged by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate PK in plasma and ELF of Peramivir, the ratio ELF:plasma of Peramivir.

Secondary Outcome Measures

Name	Time	Method
To evaluate inflammatory cytokines (IL-1, IL-2, IL-6, IL-10, pro-calcitonine, etc) in serum after BMS.