Unique ID issued by UMIN | UMIN000036939 |
---|---|
Receipt number | R000042094 |
Scientific Title | Clinical research about the change factors for amount of drug in stratum corneum(lanoconazole cream, solution) |
Date of disclosure of the study information | 2019/06/21 |
Last modified on | 2020/08/27 17:38:17 |
Clinical research about the change factors for amount of drug in stratum corneum(lanoconazole cream, solution)
Clinical research about the change factors for amount of drug in stratum corneum
Clinical research about the change factors for amount of drug in stratum corneum(lanoconazole cream, solution)
Clinical research about the change factors for amount of drug in stratum corneum
Japan |
healthy volunteer
Adult |
Others
NO
To investigate influential factors on amount of drug in stratum corneum by conducting dermato-pharmacokinetic study under several conditions
Pharmacokinetics
Exploratory
Not applicable
Amount of lanoconazole in stratum corneum in each application time points by 24 hours after drug application
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Educational,Counseling,Training
Maneuver |
Topical application of lanoconazole and sampling of stratum corneum by using several methods
20 | years-old | <= |
35 | years-old | > |
Male
(1)20 to 34 years at the time of obtaining informed consent
(2) BMI>=18.5, <25.0
(1)any medical history of illness and allergy to be conceivable that is unsuitable to enroll for the study
(2)any skin abnormality
(3)any abnormal findings in standard Labtest or vital signs
68
1st name | Kayo |
Middle name | |
Last name | Taira |
SOUSEIKAI Hakata Clinic
Clinical Pharmacology Department
812-0025
Random Square (5th-7th floors)6-18 Tenyamachi, Hakata-ku, Fukuoka 812-0025
092-283-7701
kayo-taira@lta-med.com
1st name | Akane |
Middle name | |
Last name | Yamada |
SOUSEIKAI Hakata Clinic
Department of Clinical Operations
812-0025
Random Square (5th-7th floors)6-18 Tenyamachi, Hakata-ku, Fukuoka 812-0025
092-283-7701
akane-yamada@lta-med.com
Maruho Co.,LTD.
Maruho Co.,LTD.
Profit organization
Hakata Clinic Institutional Review Board
6-18, Tenyamachi, Hakata-ku, Fukuoka 812-0025
092-283-7701
akane-yamada@lta-med.com
NO
2019 | Year | 06 | Month | 21 | Day |
Unpublished
68
Completed
2019 | Year | 04 | Month | 22 | Day |
2019 | Year | 05 | Month | 13 | Day |
2019 | Year | 06 | Month | 21 | Day |
2020 | Year | 02 | Month | 12 | Day |
2019 | Year | 06 | Month | 03 | Day |
2020 | Year | 08 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042094
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |