Study S003381

A Single Center, Open-label, Fixed Sequence Trial, Investigating the Influence of BGM0504 Injection on Gastric Emptying and Pharmacokinetics of Metformin and Warfarin in Overweight or Obese Participants

ClinicalTrials.gov record

Registration

Registration: NCT06920056
Study type: INTERVENTIONAL
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 28
Start: 2025-03-25
Primary completion: 2025-07-25
Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Conditions: Overweight or Obese
Interventions: DRUG:Paracetamol; DRUG:Metformin Hydrochloride; DRUG:Warfarin; DRUG:BGM0504
Results posted: FALSE

Registered primary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Paracetamol [From Day1 to Day72]
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Paracetamol [From Day1 to Day72]
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Metformin [From Day4 to Day76]
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin [From Day4 to Day76]
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin [From Day7 to Day84]
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin [From Day7 to Day84]

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