NCT05694221

Drug Drug Interaction (DDI) Between Supaglutide and Digoxin or Metformin

A Single-centre, Open Labeled, Fixed-sequence Study to Evaluate the Effect of Supaglutide on Digoxin or Metformin Pharmacokinetics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a study of a drug drug interaction between Supaglutide and Digoxin or Metformin.

Detailed description

This is a single-centre, open labeled, fixed-sequence study designed to assess the pharmacokinetic effects of multiple subcutaneous injections of Supalutide on a single oral dose of digoxin or multiple oral doses of metformin. 32 healthy subjects are planned to be enrolled and allocated to 2 parallel trial groups, Digoxin combined with Sulpalutide injection (Group A) and Metformin combined with Sulpalutide injection (Group B), with 16 cases in each group, of which no less than 4 were of a single sex.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Supaglutide injection	Administered subcutaneously in the Supaglutide arms
DRUG	Digoxin	Oral Administration
DRUG	Metformin	Oral Administration

Timeline

• Start date: 2023-03-20
• Primary completion: 2023-06-06
• Completion: 2023-08-17
• First posted: 2023-01-23
• Last updated: 2024-08-05

Locations

1 site across 1 country: China