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

NCT01440686 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-10-16

No results posted yet for this study

Summary

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

Conditions

  • Growth Hormone Deficiency

Interventions

DRUG

Somatropin

A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin

DRUG

Placebo

Tablets, oral administrations

Sponsors & Collaborators

  • HanAll BioPharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, Medicine · Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-12-31
Completion
2012-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01440686 on ClinicalTrials.gov