UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002578 |
|---|---|
| Receipt number | R000003143 |
| Scientific Title | Microdosing cinical studies -Assesment of oral bioavailability of drugs by cassete IV and PO dosing- |
| Date of disclosure of the study information | 2009/10/03 |
| Last modified on | 2009/10/03 05:39:23 |
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Basic information
Public title
Microdosing cinical studies -Assesment of oral bioavailability of drugs by cassete IV and PO dosing-
Acronym
Cassete microdosing study for assement of bioavailability using 3 calcium antagonisits
Scientific Title
Microdosing cinical studies -Assesment of oral bioavailability of drugs by cassete IV and PO dosing-
Scientific Title:Acronym
Cassete microdosing study for assement of bioavailability using 3 calcium antagonisits
Region
| Japan |
Condition
Condition
hypertension, arrhythmia
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purposes of this project are 1) to investigate the Miclodosing (MD) clinical study to accelerate the development of oral drug products 2) to develop a rationale method to assess the oral absorbability of drugs by MD study and 3) to simulate the human BA of drugs based on the in vitro and in vivo (MD) studies.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Each Cmax,Tmax,AUC 0-T,ACUinf,
and of T1/2 of nifedipine, nicardipine and diltiazem
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Single IV cassete microdosing of nifedipine, nicardipine and diltiazem
Interventions/Control_2
Single oral cassete microdosing of nifedipine, nicardipine and diltiazem
Interventions/Control_3
Single oral clinical dosing of nifedipine
Interventions/Control_4
Single oral clinical dosing of nicardipine
Interventions/Control_5
Single oral clinical dosing of diltiazem
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) Healthy male volunteers who are 20~40 years old
2) BMI 18.0~30.0
Key exclusion criteria
1)person who has present and/or past history of disease of heart and circulatory system, liver,kidney and uretary system, and digestive system.
2)person who has drug adiction and/or allergy
3)person who takes drugs which has an effect on the result of this study
4)person who is thoght by medical doctor as unsuitable in physical examinations and blood and biochemistry examinations.
5)person who takes drugs and/or health food product like St.John's wort within 7 days before taking study drugs
6)person who juice wfruit within 7 days before taking study drugs including grapefruitjuice
7)person who usually take health food product like St.John's wort
8)person who joined other clinical study within 3 months before this study and is thougt as unsuitable by medical doctor
9)person who donated blood of 200mL within one month and within 3 months before this study
10)person who is positive HBV,HCV,HIV and syphilis
11)person who has allergy of drug and/or food
12)person who addict drugs and alcohol
12)person who is diagonosed by medical doctors as unsuitable for joinining this study
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKUYA MORIMOTO |
Organization
Oita university hospital
Division name
Clinical pharmacology center,Japan
Zip code
Address
Hasama Idaigaoka 1-1, Yufu city, Oita prefecture
TEL
097-586-5952
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKUYA MORIMOTO |
Organization
Oita university hospital
Division name
Clinical pharmacology center
Zip code
Address
Hasama Idaigaoka 1-1, Yufu city, Oita prefecture,Japan
TEL
Homepage URL
Sponsor or person
Institute
Oita university hospital,Clinical pharmacology center
Institute
Department
Personal name
Funding Source
Organization
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
大分大学医学部附属病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | 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 | 10 | Month | 03 | Day |
Last modified on
| 2009 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003143
