Comparison of Three Liraglutide Formulations in Healthy Volunteers

Sponsor
Novo Nordisk A/S
Study ID
NCT01514487
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 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously

Study Details

This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.

Key Dates

Start date
Jan 13, 2005
Status verified
Feb 2017
Primary completion
Mar 30, 2005
Completion
Mar 30, 2005

Study Design

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

Arms

  • Experimental: pH 7.7
  • Experimental: pH 7.9
  • Experimental: pH 8.15

Primary Outcome Measure

Area under the Curve (0-t)

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