UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025222
Receipt number 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 09:11:34

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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 or person

Institute

Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Kyushu University

Institute

Department

Personal name



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

Value
https://center6.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