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RECRUITING
NCT07128888
PHASE1

Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection

Sponsor: Gan & Lee Pharmaceuticals.

View on ClinicalTrials.gov

Summary

This is a single-center, open-label, fixed-sequence phase I clinical study to evaluate the effect of GZR18 Injection on gastric emptying and the effect of repeated SC injections of GZR18 Injection on the pharmacokinetics of oral digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets. A total of 60 obese or overweight subjects are planned to be enrolled, with no less than one-quarter of the subjects from either gender. The study duration for each subject in this study is approximately 26 weeks: including a screening period of up to 4 weeks (W-28 to D-1), single-drug administration and dose escalation stages of 16 weeks (W1D1 to W16D7) and the combined drug administration stage of 6 weeks (W17D1 to W23D1)

Official title: A Study to Evaluate the Effect of GZR18 Injection on Gastric Emptying and Its Drug-Drug Interactions With Digoxin, Rosuvastatin Calcium and Warfarin Sodium in Obese or Overweight Subjects

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-11-17

Completion Date

2026-07-05

Last Updated

2025-12-12

Healthy Volunteers

No

Interventions

DRUG

GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets

GZR18 injection: 3 mg-36 mg,16 weeks; Warfarin Sodium Tablets:2.5mg,twice; Rosuvastatin Calcium Tablets:10mg,twice; Digoxin Tablets:0.25mg,twice

Locations (1)

Study site 01

Beijing, China