UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacokinetic study of levodopa coadministration of lactoferrin in healthy volunteers
Title of the study (Brief title)	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	MASAHIRO NOMOTO
Organization	Ehime university
Division name	Department of Neurology and Clinical Pharmacology
Address	454 Shitsukawa, Toon, Ehime, Japan
TEL	089-960-5095
Email	nomoto@m.ehime-u.ac.jp

Public contact
Name of contact person	MASAHIRO NAGAI
Organization	Ehime university
Division name	Department of Neurology and Clinical Pharmacology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030749