UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039823 |
|---|---|
| Receipt number | R000045416 |
| Scientific Title | pharmacokinetic study of TW-50411N-2 |
| Date of disclosure of the study information | 2020/03/15 |
| Last modified on | 2020/03/15 17:02:35 |
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Basic information
Public title
pharmacokinetic study of TW-50411N-2
Acronym
pharmacokinetic study of TW-50411N-2
Scientific Title
pharmacokinetic study of TW-50411N-2
Scientific Title:Acronym
pharmacokinetic study of TW-50411N-2
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
comparing biological equivalence between TW-50411N-2 and original drug.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cmax
AUCt
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TW-50411N-2, washout, original drug
Interventions/Control_2
original drug, washout,TW-50411N-2
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)People who receive enough explanation for this test drug and the aim and the content of this study, and who voluntarily obtain informed consent
(2)18.5=<BMI<25.0(truncating the numbers beyond the first decimal point.)
(3)People who comply with rules determined for this study
(4)People who are judged as eligible based on the result of screening tests, their back ground(history, allergy, favorites, etc.), physical findings, physical examinations, ECG, clinical laboratory test and so on by principal or sub investigators
(5)People who agree with appropriate contraception after the consent to the end of post-observation(14days after drug dosage in second period)
Key exclusion criteria
(1)People who have diseases under treatment
(2)People who have or had any disease of heart, liver, kidney, metabolic, alimentary tract, blood, respiratory and psychology, and who are judged as not eligible by principal or sub investigators
(3)People who are in clinical tests below
1)Platelets count is low
2)Plasma potassium is out of range
3)AST(GOT), ALT(GPT), total bilirubin beyond upper limit
4)HbA1c is beyond upper limit
(4)People whose blood pressure is SBP>=140 or DBP>=90 in screening or before drug dosage in first period
(5)People who have abnormal finding in chest X-ray photo at the examination before drug dosage in first period
(6)People who have history or present illness of hypersensitivity or allergy for drugs
(7)People who have dependence to drugs or alcohol and who are positive in urine drug test
(8)People who are smoking or has history of smoking in 6 months.
(9)People who are positive for infectious diseases test
(10)People who have a history of stomach resection or any abdominal operation supposed to effect absorption for the drug.
(11)People who were or will be given any drugs in another clinical trials in 12 weeks.
(12)People who underwent or will undergo collecting blood more than 400ml of total blood in 12 weeks or 200ml of total blood in 2 weeks or component (plasma component or platelets component) collecting blood in 2 weeks.
(13)People who have taken any drugs(prescription drug, OTC drug, herbal medicine, vitamins, and supplements) in 2 weeks before drug dosage or who will take nay drugs except test drugs before the end of this study
(14)People who have taken or takes citrus fruits including grape fruits except lemon or their processed food in 2 weeks before drug dosage.
(15)People who took or take food containing St johns wort 2 weeks before drug dosage.
(16)People who will have taken or will take alcohol before 3 days before drug dosage.
(17)People who are judged as not eligible by principal or sub investigators
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Maruyama |
Organization
The University of Tokyo Hospital
Division name
Clinical Research Promotion Center
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-ku Tokyo
TEL
03-5800-9515
tmaruyama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Maruyama |
Organization
The University of Tokyo Hospital
Division name
Clinical Research Promotion Center
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-ku Tokyo
TEL
03-5800-9515
Homepage URL
tmaruyama-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Towa Pharmaceutical Co., Ltd.
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
The University of Tokyo Hospital
Address
7-3-1 Hongo Bunkyo-ku Tokyo
Tel
03-5800-9515
tmaruyama-tky@umin.ac.jp
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
| 2020 | Year | 03 | Month | 15 | 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
26
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
| 2019 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 15 | Day |
Last modified on
| 2020 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045416
