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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005923
Receipt No. R000007006
Scientific Title Phase 1 comparative study of intravenous formulation of acetaminophen and oral formulation of acetaminophen
Date of disclosure of the study information 2011/08/22
Last modified on 2011/11/01

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Basic information
Public title Phase 1 comparative study of intravenous formulation of acetaminophen and oral formulation of acetaminophen
Acronym Phase 1 comparative study of intravenous formulation of acetaminophen and oral formulation of acetaminophen
Scientific Title Phase 1 comparative study of intravenous formulation of acetaminophen and oral formulation of acetaminophen
Scientific Title:Acronym Phase 1 comparative study of intravenous formulation of acetaminophen and oral formulation of acetaminophen
Region
Japan

Condition
Condition Healthy male subjects
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Infectious disease Geriatrics
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Obsterics and gynecology Pediatrics
Oto-rhino-laryngology Orthopedics Urology
Radiology Anesthesiology Oral surgery
Neurosurgery Cardiovascular surgery Plastic surgery
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the pharmacokinetics, safety and tolerability of TRM-1106 and oral formulation of acetaminophen in healthy Japanese adult men
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics of TRM-1106
Key secondary outcomes Safety

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The A group will receive TRM-1106 100 mL in Period 1 and Oral formulation of acetaminophen 1000 mg in Period 2.
A 6-day washout period will be given between the administration periods.
Interventions/Control_2 The B group will receive Oral formulation of acetaminophen 1000 mg in Period 1 and TRM-1106 100 mL in Period 2.
A 6-day washout period will be given between the administration periods.
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

Not applicable
Gender Male
Key inclusion criteria 1) Male subject aged at least 20 years (at the date of signing the consent form)
2) Subject who has voluntarily provided written consent prior to enrollment, and is willing to continuously participate in the Study.
3) Subject with a body weight of >=50.0 kg, and a body mass index (BMI) between 18.0 and 35.0. However, subject may participate even if outside this range. In such a case, the investigator or sub-investigator must determine whether it is medically tolerable.
4) Subject without any medically significant abnormality in clinical symptoms or signs (in the results of medical examinations, laboratory tests, and physiological tests)
5) Subject who can take effective contraceptive measures during the study period.
Key exclusion criteria 1) Subject who has been tested positive in a urine drug test or has a history of drug abuse.
2) Subject who has been tested positive for HBs antigen, HCV antibody or HIV antibody, or who has a positive serological test for syphilis.
3) Subject who has a history of hypersensitivity or allergy to the study drug (active component and additives)
4) Subject who currently has or has a history of peptic ulcer; or subject who currently has or has a history of asthma.
5) Subject with clinically significant disease related to the heart, liver, kidneys, respiratory system, gastrointestinal system, endocrine system, immune system, skin, blood, or psychiatric/nervous system.
6) Subject who has liver function test values (T-Bil/D-Bil, ALT (GPT), AST (GOT), gamma-GTP and ALP) that exceed the facility's upper limit. However, if the investigator deems that the reason for exceeding the limit is not due to the liver, the subject may be enrolled.
7) Subject who currently has or have a history of clinically significant bleeding or bleeding tendency.
8) Subject who has taken other medication or supplements within 1 week prior to study drug administration.
9) Subject who need to take other medication concurrently while participating in this study.
10) Subject who smoked tobacco within 1 month prior to study drug administration.
11) Subject who habitually consume a large amount of alcohol (ingestion of >=60 g per day as pure alcohol), or have ingested alcohol within 3 days prior to study drug administration.
12) Subject who has ingested food products containing St. John's wort within 2 weeks prior to study drug administration.
13) Subjects who has ingested grapefruit or processed grapefruit products within 1 week prior to study drug administration.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Nakatani
Organization Hosen Clinic, Research Center for Clinical Pharmacology, Kitasato University
Division name Internal medicine
Zip code
Address 1-28-16 Komagome, Toshima-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Yamamoto
Organization Terumo Corporation
Division name Clinical Development Department
Zip code
Address 1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan
TEL
Homepage URL
Email

Sponsor
Institute Terumo Corporation
Institute
Department

Funding Source
Organization Terumo Corporation
Organization
Division
Category of Funding Organization Profit organization
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 08 Month 22 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 05 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 08 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 07 Month 05 Day
Last modified on
2011 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007006

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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