UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025222
Receipt No. R000029019
Scientific Title Evaluation of the effect of magnesium oxide on the pharmacokinetics of levodopa/carbidopa
Date of disclosure of the study information 2016/12/13
Last modified on 2017/06/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of the effect of magnesium oxide on the pharmacokinetics of levodopa/carbidopa
Acronym pharmacokinetic interaction between levodopa/carbidopa and magnesium oxide
Scientific Title Evaluation of the effect of magnesium oxide on the pharmacokinetics of levodopa/carbidopa
Scientific Title:Acronym pharmacokinetic interaction between levodopa/carbidopa and magnesium oxide
Region
Japan

Condition
Condition healthy male and female
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the effect of magnesium oxide on the pharmacokinetics of levodopa/carbidopa
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pharmacokinetics of levodopa and carbidopa
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 levodopa/carbidopa, wash out, with magnesium oxide
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
45 years-old >=
Gender Male and Female
Key inclusion criteria The investigators must ensure that all subjects being considered meet the following
inclusion criteria:
1) Japanese healthy male or female who is capable to understand and sign the informed consent
2) 20-45 years of age
3) BMI 17.6-26.4
4) good health as determined by physical examination, vital signs and laboratory tests.
Key exclusion criteria The investigators must ensure that all subjects being considered meet the following
exclusion criteria or conditions:
1) history of allergy to any drugs
2) medical attention within 2 months prior to participation
3) donation of 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation
4) donation of 400 mL or more of blood within 12 weeks prior to participation
5) recent (past 4 months) participation in other clinical trial for investigational new chemical entity
6) history of drug abuse
7) alcohol abuse.
8) taking drugs or healthy foods which may affect drug metabolism
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunji Matsuki
Organization LTA
Division name Fukuoka Mirai Hospital
Zip code
Address 3-5-1, Kashiiteruha, Higashi-ku, Fukuoka
TEL 092-662-3608
Email shunji-matsuki@lta-med.com

Public contact
Name of contact person
1st name
Middle name
Last name Miyuki Kimura
Organization LTA
Division name Fukuoka Mirai Hospital
Zip code
Address 3-5-1, Kashiiteruha, Higashi-ku, Fukuoka
TEL 092-662-3608
Homepage URL
Email miyuki-kimura@lta-med.com

Sponsor
Institute Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Japan Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 12 Month 13 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
2016 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 20 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
2016 Year 12 Month 12 Day
Last modified on
2017 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029019

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.