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

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

Inclusion criteria

• Male or female, 18-45 years old, inclusive;
• BMI: 20.0 to 30.0 kg/m2 , body weight: ≥50.0kg.
• Ability and willingness to participate in the study, give written informed consent, and comply with the study requirements and all protocol procedures.

Exclusion criteria

• Presence of clinically significant conditions (including but not limited to respiratory system, cardiovascular system, gastrointestinal system, endocrine system, immune system, integumentary system, nervous system, ENT or other related diseases);
• History of allergic diseases including asthma, urticaria or eczema, or history of sensitivity to GLP-1 products, digoxin, warfarin, rosuvastatin or metformin;
• Known difficulty in swallowing tablets or history of gastrointestinal diseases affecting drug absorption;
• History of receiving any procedures that might affect drug absorption, distribution, metabolism or excretion;
• History of acute or chronic pancreatitis;
• History of documented or suspected hypoglycemic episodes within 6 months prior to screening;