UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012965 |
|---|---|
| Receipt number | R000015157 |
| Scientific Title | Measurement of plasma concentrations of yokukansan in form of suppository to healthy Japanese volunteers |
| Date of disclosure of the study information | 2014/01/26 |
| Last modified on | 2015/08/27 16:02:35 |
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Basic information
Public title
Measurement of plasma concentrations of yokukansan in form of suppository to healthy Japanese volunteers
Acronym
Pharmacokinetics of yokukansan component in form of suppository to healthy Japanese volunteers
Scientific Title
Measurement of plasma concentrations of yokukansan in form of suppository to healthy Japanese volunteers
Scientific Title:Acronym
Pharmacokinetics of yokukansan component in form of suppository to healthy Japanese volunteers
Region
| Japan |
Condition
Condition
healthy Japanese volunteers
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the pharmacokinetics of yokukansan component in the form of suppository, we measure the plasma concentration of yokukansan alkaloid such as hirsuteine or geissoschizine methyl ether after administration. In addition, we measure the concentration after oral administration of yokukansan to investigate the difference of pharmacokinetics due to administration route.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time course of plasma levels of hirsuteine and geissoschizine methylether after enteric administration of yokukansan
Key secondary outcomes
Time course of plasma levels of hirsuteine and geissoschizine methylether after oral administration of yokukansan
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Blood sampling time: before, and 0.5, 1, 2, and 4 hour after the enteric administration with 7.5g yokukansan
Blood sampling time: before, and 0.5, 1, 2, and 4 hour after the oral administration with 7.5g yokukansan
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a) Healthy volunteers
b) Agreement to sign an informed consent
Key exclusion criteria
a) Patients who are allergic to medicines, or foods related to the test material of this trial
b) Pregnant women, lactating women, or women who want to get pregnant during the trial period
c) Patients who are enrolled in the other clinical trials before the agreement for the participation to this trial
d) Patients who are judged not suitable to participate in this trial by physician.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoko Kawahara |
Organization
Nissay Hospital
Division name
Anesthesiology and Palliative care
Zip code
Address
6-3-8, Itachibori, Nishi-ku, Osaka, 550-0012
TEL
06-6543-3581
kawahara.ryoko@nissay-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoko Kawahara |
Organization
Nissay Hospital
Division name
Anesthesiology and Palliative care
Zip code
Address
6-3-8, Itachibori, Nishi-ku, Osaka, 550-0012
TEL
06-6543-3581
Homepage URL
kawahara.ryoko@nissay-hp.or.jp
Sponsor or person
Institute
Nissay Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 26 | Day |
Last modified on
| 2015 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015157
