UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026787 |
|---|---|
| Receipt number | R000030749 |
| Scientific Title | Pharmacokinetic study of levodopa coadministration of lactoferrin in healthy volunteers |
| Date of disclosure of the study information | 2017/03/30 |
| Last modified on | 2017/10/02 14:53:04 |
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Basic information
Public title
Pharmacokinetic study of levodopa coadministration of lactoferrin in healthy volunteers
Acronym
PK study of levodopa coadministration of lactoferrin
Scientific Title
Pharmacokinetic study of levodopa coadministration of lactoferrin in healthy volunteers
Scientific Title:Acronym
PK study of levodopa coadministration of lactoferrin
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of lactoferrin on pharmacokinetics of levodopa.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
AUC, Cmax, tmax, elimination half-life of levodopa
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Levodopa100mg/beserazide25mg Tablet single dose
Lactoferrin powder 1g single dose
Interventions/Control_2
Levodopa100mg/beserazide25mg Tablet single dose
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adult
Key exclusion criteria
known allergy to milk product
Any disorder which needs regular office visit
History of severe heart disorders,renal insufficiency, hepatic insufficiency or malignancy
Investigators judge as an inadequate subject to enroll this study
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MASAHIRO NOMOTO |
Organization
Ehime university
Division name
Department of Neurology and Clinical Pharmacology
Zip code
Address
454 Shitsukawa, Toon, Ehime, Japan
TEL
089-960-5095
nomoto@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MASAHIRO NAGAI |
Organization
Ehime university
Division name
Department of Neurology and Clinical Pharmacology
Zip code
Address
454 Shitsukawa, Toon, Ehime, Japan
TEL
089-960-5095
Homepage URL
mnagai@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime university
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 03 | Month | 30 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 09 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 30 | Day |
Last modified on
| 2017 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030749
