UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004309 |
|---|---|
| Receipt number | R000005167 |
| Scientific Title | The influence of nucleoside transporter on pharmacokinetics, effect and adverse events of ribavirin |
| Date of disclosure of the study information | 2010/10/02 |
| Last modified on | 2016/04/01 09:45:25 |
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Basic information
Public title
The influence of nucleoside transporter on pharmacokinetics, effect and adverse events of ribavirin
Acronym
The influence of nucleoside transporter on pharmacokinetics, effect and adverse events of ribavirin
Scientific Title
The influence of nucleoside transporter on pharmacokinetics, effect and adverse events of ribavirin
Scientific Title:Acronym
The influence of nucleoside transporter on pharmacokinetics, effect and adverse events of ribavirin
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The Investigation of drug interaction between ribavirin and nucleoside transporter inhibitor
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetics of ribavirin
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of ribavirin without nucleoside transporter inhibitor
Interventions/Control_2
Administration of ribavirin with nucleoside transporter inhibitor
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
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy male subjects
2) Older than 20 years, younger than 50 years
3) Weight less than 90 kg, and body mass index(BMI) of 18.5-25.0
4) Written informed consent
Key exclusion criteria
1) Anemia
2) Virus infection last 4 weeks prior to the study
3) Medication last 2 weeks prior to the study
4) Participation in a clinical trial last 3 months prior to the study
5) Intake of alcohol last 48 hours prior to the study
6) Blood donation more than 400 mL last 6 months prior to the study
7) Possible the autoimmune disease
8) Allergic reaction
9) Alcohol or drug abuse
10) Positive for HBs antigen, HCV antibody, and syphilis
11) Other inappropriate cases
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Homma |
Organization
Tsukuba University Hospital
Division name
Pharmacy Department
Zip code
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
029-853-3843
masatoh@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiharu Suzuki |
Organization
Tsukuba University Hospital
Division name
Pharmacy Department
Zip code
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
02-853-3843
Homepage URL
suzukiyo@hosp.tsukuba.ac.jp
Sponsor or person
Institute
Tsukuba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 10 | Month | 02 | 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
| 2010 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | 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
| 2010 | Year | 10 | Month | 01 | Day |
Last modified on
| 2016 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005167
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
