Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers

Sponsor
Novo Nordisk A/S
Study ID
NCT01515553
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period

Study Details

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned for phase 3b trials (final formulation 4).

Key Dates

Start date
Jan 31, 2007
Status verified
Jan 2015
Primary completion
Apr 30, 2007
Completion
Apr 30, 2007

Study Design

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

Arms

  • Experimental: Formulation 4
  • Experimental: Final formulation 4

Primary Outcome Measure

Area under the curve (0-t)

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