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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002708
Receipt No. R000003292
Scientific Title Pharmacokinetics interaction between gabapentin and antacids.
Date of disclosure of the study information 2009/11/04
Last modified on 2011/02/15

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Basic information
Public title Pharmacokinetics interaction between gabapentin and antacids.
Acronym Pharmacokinetics interaction between gabapentin and antacids.
Scientific Title Pharmacokinetics interaction between gabapentin and antacids.
Scientific Title:Acronym Pharmacokinetics interaction between gabapentin and antacids.
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate drug interaction between gabapentin and antacids.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes gabapentin concentration in plasma and urine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Take gabapentin
Interventions/Control_2 Take gabapentin and antacid 1
Interventions/Control_3 Take gabapentin and antacid 2
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

Not applicable
Gender Male
Key inclusion criteria healthy volunteer
Key exclusion criteria renal dysfunction
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Kawakami
Organization Department of Hospital Pharmacy
Hamamatsu University School of Medicine
Division name Hospital Pharmacy
Zip code
Address 1-20-1 Handayama, Hamamatsu 431-3192, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Department of Hospital Pharmacy Hamamatsu University School of Medicine
Division name Hospital Pharmacy
Zip code
Address
TEL 053-435-2765
Homepage URL
Email

Sponsor
Institute Department of Hospital Pharmacy
Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Japan Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 11 Month 04 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
2009 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2010 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 04 Day
Last modified on
2011 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003292

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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