NCT06335134

A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

A Single-Center, Open-Label Study to Evaluate the Effect of XW003 Injection on the Pharmacokinetics of Metformin, Warfarin, Rosuvastatin or Digoxin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

Detailed description

This is a single-center, open-label, fixed-sequence study designed to assess the effect of once-weekly subcutaneous injections of XW003 on the pharmacokinetics of metformin, warfarin, rosuvastatin or digoxin. Approximately 56 healthy subjects are to be enrolled into 2 parallel trial groups, with 28 subjects and 2 drugs evaluated in each of the trial group

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	XW003 injection	Administered subcutaneously
DRUG	Metformin	Administered orally
DRUG	Warfarin	Administered orally
DRUG	Rosuvastatin	Administered orally
DRUG	Digoxin	Administered orally

Timeline

• Start date: 2023-07-14
• Primary completion: 2024-01-08
• Completion: 2024-06-28
• First posted: 2024-03-28
• Last updated: 2025-05-08

Locations

1 site across 1 country: China