Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

Sponsor
Novo Nordisk A/S
Study ID
NCT02249871
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    All subjects will be treated for 10 consecutive days including dose escalation, with 5 days on 5 mg oral semaglutide followed by 5 days on 10 mg oral semaglutide.
  • Omeprazole — DRUG
    Will be given daily with oral semaglutide.

Study Details

This trial is conducted in Europe. The aim of this trial is to investigate the influence of omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide in healthy subjects.

Key Dates

Start date
Sep 24, 2014
Status verified
Aug 2018
Primary completion
Apr 1, 2015
Completion
Apr 1, 2015

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
  • Experimental: Semaglutide + Omeprazole

Primary Outcome Measure

Area under the semaglutide plasma concentration time curve [ Time Frame: From time 0 to 24 hours after the 10th daily dose ]

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