Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors

Sponsor
Novo Nordisk A/S
Study ID
NCT02207348
Phase
PHASE1
Status
Completed

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)

Study Details

This trial is conducted in Europe. The aim of this trial is to investigate bioequivalence between single-dose liraglutide administered subcutaneously with two different pen-injectors.

Key Dates

Start date
Aug 31, 2014
Status verified
Dec 2016
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

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

Arms

  • Experimental: Liraglutide 0.6 mg s.c. with FlexPen®
  • Experimental: Liraglutide 0.6 mg s.c. with the PDS290 pen-injector

Primary Outcome Measure

Area under the liraglutide plasma concentration time curve from 0 to last quantifiable observation (tz) after single dose [ Time Frame: 0-72 hours following administration of 0.6 mg liraglutide ]

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