Brief Title
Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers
Official Title
A Dose Block-randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of HL-032 in Healthy Male Volunteers
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of
HL-032 after oral administration in healthy male volunteers.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Area under the serum hGH(human growth hormone)concentration-time curve
Secondary Outcome
Area under the effect(IGF-1, IGFBP-3, NEFA)curve
Condition
Growth Hormone Deficiency
Intervention
Somatropin
Study Arms / Comparison Groups
HL-032 30mg
Description: A single dose 30mg administered orally
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
September 2011
Completion Date
January 2012
Primary Completion Date
December 2011
Eligibility Criteria
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
Gender
Male
Ages
19 Years - 50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Kyung-Sang Yu, Medicine, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01440686
Organization ID
HGR10I_1
Responsible Party
Sponsor
Study Sponsor
HanAll BioPharma Co., Ltd.
Study Sponsor
Kyung-Sang Yu, Medicine, Principal Investigator, Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
Verification Date
October 2012