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

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Brief Title

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

Official Title

A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24)

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 identify somatostatin-related adverse events.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Area under the hGH concentration-time curve (GH AUC0-24h)

Secondary Outcome

 Time to maximum hGH concentration (GH tmax)

Condition

Growth Hormone Disorder

Intervention

somatropin


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

86

Start Date

April 6, 2000

Completion Date

June 8, 2000

Primary Completion Date

June 8, 2000

Eligibility Criteria

        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
      

Gender

Male

Ages

20 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Global Clinical Registry (GCR, 1452), , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00931476

Organization ID

GHKIN-1253


Responsible Party

Sponsor

Study Sponsor

Novo Nordisk A/S


Study Sponsor

Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S


Verification Date

February 2017