UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002347 |
|---|---|
| Receipt number | R000001990 |
| Scientific Title | Effects of the timing of administration of oral small spherical activated charcoal (Kremezin) on the pharmacokinetics and pharmacodynamics of triazolam in humans |
| Date of disclosure of the study information | 2009/08/20 |
| Last modified on | 2012/12/20 09:23:44 |
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Basic information
Public title
Effects of the timing of administration of oral small spherical activated charcoal (Kremezin) on the pharmacokinetics and pharmacodynamics of triazolam in humans
Acronym
Interaction between activated charcoal and triazolam
Scientific Title
Effects of the timing of administration of oral small spherical activated charcoal (Kremezin) on the pharmacokinetics and pharmacodynamics of triazolam in humans
Scientific Title:Acronym
Interaction between activated charcoal and triazolam
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the timing of administration of small spherical activated charcoal (Kremezin) affects the pharmacokinetics and pharmacodynamics of triazolam in humans
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
plasma triazolam concentrations
subjective drowsiness
psychomotor performance (digit symbol substitution test)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1)triazolam alone,2)simultaneous administration of triazolam and small spherical activated chaecol(Kremezin),3)triazolam administration 60 min after Kremezin,4)triazolam administration 30 min after Kremezin
Interventions/Control_2
1)simultaneous administration of triazolam and Kremezin,2)triazolam administration 30 min after Kremezin,3)triazolam alone,4)triazolam administration 60 min after Kremezin
Interventions/Control_3
1)triazolam administration 30 min after Kremezin,2)triazolam administration 60 min after Kremezin,3)simultaneous administration of triazolam and Kremezin,4)triazolam alone
Interventions/Control_4
1)triazolam administration 60 min after Kremezin,2)triazolam alone,3)triazolam administration 30 min after Kremezin,4)simultaneous administration of triazolam and Kremezin
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)written informed consent before the study
2)volunteers ascertained to be healthy by a medical history, a physical examination, electrocardiogram, whole blood cell counts, serum chemical analysis and urinalysis.
Key exclusion criteria
1)smokers
2)pregnant women
3)nursing women
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Kotegawa |
Organization
Oita University Faculty of Medicine
Division name
Clinical Pharmacology and Therapeutics
Zip code
Address
Idaigaoka1-1, Hasama-machi, Yufu, Oita 879-5593
TEL
097-586-5952
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Kotegawa |
Organization
Oita University Faculty of Medicine
Division name
Clinical Pharmacology and Therapeutics
Zip code
Address
Idaigaoka1-1, Hasama-machi, Yufu, Oita 879-5593
TEL
097-586-5952
Homepage URL
kotet@med.oita-u.ac.jp
Sponsor or person
Institute
Dept. of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
KUREHA CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2009 | Year | 08 | Month | 20 | 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 | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 18 | Day |
Last modified on
| 2012 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001990
