Study S002798

A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of UBT251 on the Pharmacokinetics of Single Oral Doses of Metformin, Warfarin, Atorvastatin, and Digoxin in Overweight or Obese Participants.

ClinicalTrials.gov record

Registration

Registration: NCT07785934
Study type: INTERVENTIONAL
Phase: PHASE1
Masking: NONE
Status: RECRUITING
Enrollment: 48
Start: 2026-05-27
Primary completion: 2026-12
Lead sponsor: The United Bio-Technology (Hengqin) Co., Ltd.
Conditions: Drug Drug Interaction (DDI); Pharmacokinetics and Pharmacodynamics
Interventions: DRUG:UBT251; DRUG:Metformin hydrochloride; DRUG:Warfarin Sodium; DRUG:Atorvastatin calcium; DRUG:Digoxin
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Area under plasma concentration-time curve of metformin (AUC0-τ) and S-warfarin, R-warfarin (AUC0-t, AUC0-∞) [From time 0 to 30 hours (metformin, post last dose) and 168 hours (S-warfarin, R-warfarin) after respective doses]
Area under plasma concentration-time curve (AUC0-t and AUC0-∞) of atorvastatin and digoxin [From time 0 to 72 hours (atorvastatin) and 120 hours (digoxin) after respective single doses]

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