UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013873 |
|---|---|
| Receipt number | R000016180 |
| Scientific Title | Bioequivalence study of NIG-2059 in healthy adults. |
| Date of disclosure of the study information | 2014/05/02 |
| Last modified on | 2015/05/07 18:54:55 |
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Basic information
Public title
Bioequivalence study of NIG-2059 in healthy adults.
Acronym
Bioequivalence study of NIG-2059 in healthy adults.
Scientific Title
Bioequivalence study of NIG-2059 in healthy adults.
Scientific Title:Acronym
Bioequivalence study of NIG-2059 in healthy adults.
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the bioequivalence of NIG-2059 and EXFORGE Combination Tablets
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
AUCinf
Tmax
MRT
kel
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
NIG-2059, washout,
EXFORGE Combination Tablets
Interventions/Control_2
EXFORGE Combination Tablets, washout, NIG-2059
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy male subjects between the ages of 20 and 35 years when at informed consent.
2) Body Mass Index between 18.5 to 25.0 kg/m2.
3) Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during screening. Some of the laboratory values e.g complete blood count etc that is out of the normal or reference range will be carefully considered by the clinical investigator.
4) Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria
1) History of hypersensitivity for any elements involved in all the investigational agents in this study
2) Subjects who have history of hypersensitivity to dihydropyridine compound
3) Diabetic subject given aliskiren
4) Renal artery stenosis, bilaterally or unilaterally after nephrectomy
5) Hyperkalemia
6) Serious renal dysfunction
7) Liver dysfunction, especially biliary liver cirrhosis or cholestasis
8) Cerebrovascular disorders
9) Serological reaction of syphilis, HBsAg, HCVAb or HIVAb positive
10) AST(GOT) or ALT(GPT) more than the reference value by screening or clinical assay before the administration in each term(excluding the case of AST or ALT value within the standard value by reexamination)
11) Subjects who have present or past history of cardiovascular system, immune system, hematologic, brain vasculature, respiratory system, digestive system, liver or renal disease
12) History of gastrointestinal tract surgery which has an affect on the drug absorption such as gastrectomy, gastrointestinal suture, or intestinal resection
13) Presence of alcohol or drug dependency
14) Subjects who need some cure for actual allergic symptom, such as asthma, pollinosis, or atopic dermatitis
15) Subjects who use other medicine in the week prior to administration of 1st period or need to take other medicine during the test (including external preparation etc.)
16) Enrolled in another investigational study and took other investigational drug within 4 months(if it is a patch test, within one month)
17) Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood content within 2 weeks prior to the time of consent.
18) Subjects who are judged ineligible for entry to this study by the study physician
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Moritoyo |
Organization
The University of Tokyo Hospital
Division name
Unit for Early and Exploratory Clinical Development
Zip code
Address
7-3-1 Hongo,Bunkyo-ku,Tokyo
TEL
03-5800-9083
moritoyo-tky@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiharu Nakane |
Organization
Nichi-Iko Pharmaceutical Co., Ltd
Division name
Dept. of Clinical Study
Zip code
Address
205-1 Shimoumezawa, Namerikawa City, Toyama Prefecture, Japan
TEL
076(475)5767
Homepage URL
t-nakane@nichiiko.co.jp
Sponsor or person
Institute
Nichi-Iko Pharmaceutical Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
東京大学医学部附属病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 02 | 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
| 2014 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 11 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 11 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 02 | Day |
Last modified on
| 2015 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016180
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