NCT05429593

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

A Study Comparing Exposure of Semaglutide and Dapagliflozin Dosed Orally as Mono-components Versus in a Fixed-dose Combination

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Semaglutide	Tablet given orally
DRUG	Dapagliflozin	Tablet given orally
DRUG	Semaglutide/dapagliflozin	Tablet given orally

Timeline

• Start date: 2022-06-22
• Primary completion: 2023-03-10
• Completion: 2023-04-13
• First posted: 2022-06-23
• Last updated: 2024-08-07

Locations

2 sites across 1 country: Germany