A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes

Sponsor
Novo Nordisk A/S
Study ID
NCT01766245
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    For subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits.

Study Details

This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between subcutaneous injections of semaglutide produced by two manufacturing processes.

Key Dates

Start date
Dec 31, 2012
Status verified
Jun 2014
Primary completion
May 31, 2013
Completion
May 31, 2013

Study Design

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

Arms

  • Experimental: Formulation A followed by Formulation B
  • Active Comparator: Formulation B followed by Formulation A

Primary Outcome Measure

Area under the plasma semaglutide concentration curve [ Time Frame: 0-4 weeks after a single dose s.c. semaglutide administration ]

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