A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects

Sponsor
Novo Nordisk A/S
Study ID
NCT00813020
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • semaglutide — DRUG
    Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses
  • semaglutide — DRUG
    Comparison of different formulations of the drug, semaglutide: Formulation 2 administered in equimolar doses
  • semaglutide — DRUG
    Comparison of different formulations of the drug, semaglutide: Formulation 3 administered in equimolar doses

Study Details

This trial is conducted in Europe. The aim of this clinical trial is to investigate whether differences exist between three different concentrations of the drug, NN9535, administered in healthy male subjects in equal doses.

Key Dates

Start date
Jan 31, 2009
Status verified
Feb 2015
Primary completion
Apr 30, 2009
Completion
Apr 30, 2009

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: A
  • Experimental: B
  • Experimental: C

Primary Outcome Measure

AUC0-8 (NN9535), the area under the plasma NN9535 plasma-concentration-time curve in the interval 0-8 after investigational medicinal product administration [ Time Frame: a 28 day time period ]

Related Studies