A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet

Sponsor
Novo Nordisk A/S
Study ID
NCT05429593
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This study will test how the active substances semaglutide and dapagliflozin act in the body (in terms of their levels in the blood), when they are taken in the form of a combination preparation (a tablet with a fixed dose combination) compared to when oral semaglutide and dapagliflozin are given alone.The study will consist of 2 parts. Part 1 will compare semaglutide to the fixed dose combination tablet (semaglutide/dapagliflozin) and part 2 will compare dapagliflozin to the fixed dose combination tablet (semaglutide/dapagliflozin). Participants will take part in either part 1 or part 2.

Key Dates

Start date
Jun 22, 2022
Status verified
Aug 2024
Primary completion
Mar 10, 2023
Completion
Apr 13, 2023

Study Design

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

Arms

  • Experimental: Part 1 sequence A
    Semaglutide followed by Semaglutide/dapagliflozin
  • Experimental: Part 1 sequence B
    Semaglutide/dapagliflozin followed by Semaglutide
  • Experimental: Part 2 sequence A
    Dapagliflozin followed by Semaglutide/dapagliflozin
  • Experimental: Part 2 sequence B
    Semaglutide/dapagliflozin followed by dapagliflozin

Primary Outcome Measure

AUC0-24h,sema,ss: area under the semaglutide plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state [ Time Frame: From 0 to 24 hours on day 49 and 84 in Part 1 ]

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