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

* 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 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


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

Value
https://center6.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