Unique ID issued by UMIN | UMIN000007758 |
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Receipt number | R000009138 |
Scientific Title | Pharmacokinetics(PK) study of Peramivir in Epithelial Lining Fluid (ELF), an open-label study. |
Date of disclosure of the study information | 2012/04/14 |
Last modified on | 2019/06/21 20:59:21 |
Pharmacokinetics(PK) study of Peramivir in Epithelial Lining Fluid (ELF), an open-label study.
PK study of Peramivir in ELF
Pharmacokinetics(PK) study of Peramivir in Epithelial Lining Fluid (ELF), an open-label study.
PK study of Peramivir in ELF
Japan |
healthy volunteer
Not applicable | Adult |
Others
NO
To evaluate PK and lung translatability of Peramivir in ELF by Bronchoscopic Micro-sampling(BMS) analysis on healthy volunteers.
Pharmacokinetics
Exploratory
Explanatory
Not applicable
To evaluate PK in plasma and ELF of Peramivir, the ratio ELF:plasma of Peramivir.
To evaluate inflammatory cytokines (IL-1, IL-2, IL-6, IL-10, pro-calcitonine, etc) in serum after BMS.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine |
Infusing peramivir 300mg in a half hour
20 | years-old | <= |
Not applicable |
Male and Female
Healthy volunteers except exclusion criteria and abnormalities proved by the pre-medical test. With informed consent as volunteers.
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.
6
1st name | |
Middle name | |
Last name | Naoki Hasegawa |
Keio University Hospital School of Medicine
Infection Control Center
35, Shinanomachi, Shinjuku-ku, Tokyo, 162-8582, Japan
03-5363-3710
n-hasegawa@z8.keio.jp
1st name | |
Middle name | |
Last name | Yohei Funatsu |
Keio University Hospital, School of Medicine
Department of Medicine, Division of Pulmonary medicine
35, Shinanomachi, Shinjuku-ku, Tokyo, 162-8582, Japan
03-5363-3793
dodeko81@ybb.ne.jp
Keio University School of Medicine
SHIONOGI & CO.,LTD
Profit organization
NO
2012 | Year | 04 | Month | 14 | Day |
Published
Completed
2012 | Year | 03 | Month | 30 | Day |
2012 | Year | 03 | Month | 30 | Day |
2012 | Year | 04 | Month | 01 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2016 | Year | 10 | Month | 03 | Day |
2016 | Year | 10 | Month | 03 | Day |
2012 | Year | 04 | Month | 14 | Day |
2019 | Year | 06 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009138
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Research case data | |
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