Status:

COMPLETED

Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers

Lead Sponsor:

HanAll BioPharma Co., Ltd.

Conditions:

Growth Hormone Deficiency

Eligibility:

MALE

19-50 years

Phase:

PHASE1

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.

Eligibility Criteria

Inclusion

  • Healthy male subjects
  • Age(yr)between 19 and 50
  • Signed written informed consent

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2012

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT01440686

Start Date

September 1 2011

End Date

January 1 2012

Last Update

October 16 2012

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute

Seoul, South Korea, 110-744