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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026787
Receipt No. 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

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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
Email 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
Email mnagai@m.ehime-u.ac.jp

Sponsor
Institute Ehime university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030749

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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