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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01440686
Other study ID # HGR10I_1
Secondary ID
Status Completed
Phase Phase 1
First received September 23, 2011
Last updated October 15, 2012
Start date September 2011
Est. completion date January 2012

Study information

Verified date October 2012
Source HanAll BioPharma Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of HL-032 after oral administration in healthy male volunteers.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 2012
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria:

- Healthy male subjects

- Age(yr)between 19 and 50

- Signed written informed consent

Exclusion Criteria:

- Known hypersensitivity to Octreotide or hGH(human growth hormone)

- History of Cardiovascular, Respiratory, Renal/Genitourinary, Gastrointestinal, Neurological/Psychic, cancer

- Alcoholic, smokers or drug abusers

- Other conditions which in the opinion of the investigator preclude enrollment into the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Somatropin
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
Placebo
Tablets, oral administrations

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute Seoul

Sponsors (1)

Lead Sponsor Collaborator
HanAll BioPharma Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the serum hGH(human growth hormone)concentration-time curve From 0 to the time of the last quantifiable concentration over a 32-hour sampling period Yes
Primary Maximum observed serum hGH concentration Over a 32-hour sampling period Yes
Secondary Area under the effect(IGF-1, IGFBP-3, NEFA)curve From time 0 to the time of the last concentration(AUECO-t) over 32-hour sampling period No
Secondary Maximum IGF-1, IGFBP-3, NEFA effect Over a 32-hour sampling period No
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