Comparison of Two Liraglutide Formulations in Healthy Subjects

Sponsor
Novo Nordisk A/S
Study ID
NCT01515579
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

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

Interventions

  • liraglutide — DRUG
    One single dose of 6.25 mg/mL administered subcutaneously
  • liraglutide — DRUG
    One single dose of 6.0 mg/mL administered subcutaneously

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 at pH 8.15 (formulation 4) and liraglutide at pH 7.7 (formulation 3).

Key Dates

Start date
Apr 30, 2006
Status verified
Jan 2015
Primary completion
Jun 30, 2006
Completion
Jun 30, 2006

Study Design

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

Arms

  • Experimental: Formulation 3
  • Experimental: Formulation 4

Primary Outcome Measure

Area under the curve (0-t)

Related Studies