Status:

COMPLETED

A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Growth Hormone Disorder

Adult Growth Hormone Deficiency

Eligibility:

MALE

20-50 years

Phase:

PHASE1

Brief Summary

This trial was conducted in the United States of America (USA). The aim of this clinical trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian subjects, and to ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Signed informed consent before any trial related activities
  • Japanese and Caucasian males respectively
  • Healthy subjects based upon medical history, physical examination, vital signs, ECG, serum biochemistry and haematology and urinalysis
  • Body Mass Index (BMI) between 17 and 30 m2/kg, inclusive

Exclusion

    Key Trial Info

    Start Date :

    April 6 2000

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 8 2000

    Estimated Enrollment :

    86 Patients enrolled

    Trial Details

    Trial ID

    NCT00931476

    Start Date

    April 6 2000

    End Date

    June 8 2000

    Last Update

    February 27 2017

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Novo Nordisk Investigational Site

    Honolulu, Hawaii, United States, 96814-4224