臨床研究等提出・公開システム

Date of registration	Feb. 05, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080220995

Scientific Title	Administration study as a part of research toward the influence of growth hormone releasing peptide GHRP-2 on detection of rhGH
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Mitsubishi Chemical Medience Corporation
	Address	Shinji Kageyama 81-3-5994-2351
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		15
Study Type		Interventional
Study Design	Study Design
Study Design	Objective
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Weight: more than 50 kg and under 66kg BMI: more than 18.5 and under 25
	Exclusion Criteria	Hypersensitive to drugs, A hystory of alcoholism of drug addiction, Ethical or OTC pharmaceuticals administration within two before scheduled administration of the study, Supplement, grapefruit or its products, or foods containing Hyperrium perforatum consumed within one week before scheduled administration of the study. Not less than 200 ml of blood is collected within 30 days or not less than 400 ml of blood is collected within 90 days before scheduled administration of the study.
	Minimum Age	20age old over
	Maximum Age	40age old under
	Gender	Male
Health Condition or Problem Studied		Not applicable
Intervention(s)		investigational material(s) Generic name etc : GHRP-2 INN of investigational material : Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicines) Dosage and Administration for Investigational material : GHRP KAKEN 100R (10ug/ml in saline), containing 100ug pralmorelin dihydrochloride was administrated healthy subjects after over night fasting. control material(s) Generic name etc : Somatropin INN of investigational material : Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicines) Dosage and Administration for Investigational material : Injectable solution of rhGH (0.04 mg / kg, Somatropin®) was subcutaneous administered during fasting healthy male volunteers.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	Mitsubishi chemical Medience Corporation
Secondary Sponsor

Name of Funding Organization	Ministry of Education, Culture, Sports, Science and Technology
Name of Research Funding

Name of Funding Organization
Name of Research Funding	The 2010 Ministry of Education, Culture, Sports, Science and Technology research project fund

Name	Medical corporation Shinanokai Shinanozaka Clinic Reveiw Board
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-101028
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Aug. 11, 2011	Detail	Changes
5	Aug. 10, 2011	Detail	Changes
4	Aug. 04, 2011	Detail	Changes
3	Aug. 02, 2011	Detail	Changes
2	June. 03, 2010	Detail	Changes
1	Feb. 05, 2010	Detail

List of change history