UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004920 |
|---|---|
| Receipt number | R000005751 |
| Scientific Title | microdose study for the clarification of the mechanism of non-linear pharmacokinetics of telmisartan in the range of therapeutic doses |
| Date of disclosure of the study information | 2011/01/21 |
| Last modified on | 2012/07/23 12:56:51 |
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Basic information
Public title
microdose study for the clarification of the mechanism of non-linear pharmacokinetics of telmisartan in the range of therapeutic doses
Acronym
microdose study to clarify the non-linear pharmacokinetics of telmisartan
Scientific Title
microdose study for the clarification of the mechanism of non-linear pharmacokinetics of telmisartan in the range of therapeutic doses
Scientific Title:Acronym
microdose study to clarify the non-linear pharmacokinetics of telmisartan
Region
| Japan |
Condition
Condition
healthy adult subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify why telmisartan shows non-linear pharmacokinetics of telmisartan by observing the pharmacokinetics of telmisartan at microdose and therapeutic dose
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pharmacokinetics of telmisartan
Key secondary outcomes
PGx related to pharmacokinetics of telmisartan
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous administration (microdose of telmisartan)->(over 7days for washout)->Oral administration(microdose of telmisartan)->(over 1day for washout)->Oral administration(clinical dose of telmisartan)->(over 7days for washout)->
Oral administration(highest clinical dose of telmisartan)
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1)Ability to understand and willing to sign the informed consent.
2)Japanese healthy male subjects age 20 to 40 years of age
3)Body weight between 50 kg and 100 kg, and a body mass index(BMI)between 18.5 and 27 kg/m2.
4)Healthy subject as determined by medical history, physical examination, ECGs, and clinical laboratory tests.
Key exclusion criteria
1)Any hypersensitivities to telmisartan.
2)bile secretory failure or severe liver disorder
3)Supine systolic blood pressure under 90mmHg
4)Use of medicine, health product including Saint John's wort or garlic supplyment 2 weeks before pre-dose.
5)Intake of fruit food and drink including grapefruit juice, orange juice or apple juice from 7 days before pre-dose.
6)Participation to any other clinical reseach in the past 3 months.
7)Donating over 200 ml of blood in the past 1 month or over 400ml of blood in the past 3 months.
8)Positive tests of serological reaction for syphilis, HIV antigen and antibody, HBs antigen or HCV antibody.
9)Any allergy to drug and food
10)Drug abuse or positive drug screening
11)Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Kumagai |
Organization
Kitasato University East Hospital
Division name
Clinical trial Center
Zip code
Address
2-1-1 Asamizodai, Minami, Sagamihara, Kanagawa, 252-0380 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato University East Hospital
Division name
Clinical trial Center
Zip code
Address
2-1-1 Asamizodai, Minami, Sagamihara, Kanagawa, 252-0380 Japan
TEL
Homepage URL
Sponsor or person
Institute
Clinical trial Center,Kitasato University East Hospital
Institute
Department
Personal name
Funding Source
Organization
APDD, Association for Promoting Drug Development
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 01 | Month | 21 | 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
| 2011 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | 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
| 2011 | Year | 01 | Month | 21 | Day |
Last modified on
| 2012 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005751
| 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 |
