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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004920
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Clinical trial Center,Kitasato University East Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005751

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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