UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003637
Receipt number R000004392
Scientific Title Comparative pharmacokinetic study of acetaminophen between Japanese and Chinese(Han-people)
Date of disclosure of the study information 2010/05/19
Last modified on 2012/07/13 14:19:06

* 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

Comparative pharmacokinetic study of acetaminophen between Japanese and Chinese(Han-people)

Acronym

Pharmacokinetic study of acetaminophen

Scientific Title

Comparative pharmacokinetic study of acetaminophen between Japanese and Chinese(Han-people)

Scientific Title:Acronym

Pharmacokinetic study of acetaminophen

Region

Japan


Condition

Condition

healthy male subjects

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

to examine the differences in pharmacokinetics of acetaminophen

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pharmacokinetics of acetaminophen

Key secondary outcomes

safety
genetic analysis


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

administration of acetaminophen

Interventions/Control_2

administration of acetaminophen

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)Those who have ability to provide written consent to participate in the study.
2)Healthy male subjects between the ages of 20 and 40 years at the time of obtaining informed consent.
3)Body weight between 50 kg and 100 kg, and a body mass index(BMI)between 18.5 and 27 kg/m2.
4)Judged to be healthy by the study physician based on medical examinations and clinical laboratory tests.

Key exclusion criteria

1)Any subject with a past history of anaphylaxis due to acetaminophen.
2)Any subject with peptic ulcer.
3)Any subject with blood abnormality,hepatopathy, kidney damage or cardiac dysfunction.
4)Aspirin-induced asthma or a history of diseases of aspirin-induced asthma.
5)Alcohol drinkers (daily alcohol intake of 30 g or more in the past 3 months).
6)Use of a health food product containing Saint John's wort or use of a drug within 14 days before study drug administration.
7)Intake of any beverage or drink containing grapefruit, orange, or apple juice within 7 days of beginning study drug administration.
8)Participation in any other clinical trial within the past 3 months.
9)Persons who have donated more than 200 ml of blood in the past 1 month or more than 400 ml of blood in the past 3 months.
10)Anyone with a positive serological response for syphilis, HIV antigen or antibody, HBs antigen, or HCV antibody.
12)Anyone known to abuse drugs or who tests positive for a drug in urine screening tests.
13)Any condition that, in the opinion of the investigator, would make the patient unsuitable for inclusion in the study.

Target sample size

16


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 or person

Institute

Clinical trial Center,Kitasato University East Hospital

Institute

Department

Personal name



Funding Source

Organization

Clinical trial Center,Kitasato University East Hospital

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

2010 Year 05 Month 19 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2010 Year 04 Month 30 Day

Date of IRB


Anticipated trial start date

2010 Year 05 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

2010 Year 05 Month 19 Day

Last modified on

2012 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004392


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name