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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013873
Receipt No. 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

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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
Email 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
Email t-nakane@nichiiko.co.jp

Sponsor
Institute Nichi-Iko Pharmaceutical Co., Ltd
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016180

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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