UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002578
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Oita university hospital,Clinical pharmacology center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003143

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.