The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan, 650100, China
NCT Number: NCT06920056
The purpose of the study is to evaluate the influence of BGM0504 injection on gastric emptying and Pharmacokinetics of metformin and warfarin in overweight or obese participants
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Kunming, Yunnan, 650100, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
√ Have a body mass index (BMI) of greater than or equal to (≥)28 kilogram per square meter (kg/m²) or ≥24 kg/m2 and less than (<) 28 kg/m².
√ Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff.
Exclusion criteria
√ History of chronic or acute pancreatitis.
oral, postprandial
Oral , Fasting
Oral , Fasting
Administered SC
Time frame: From Day1 to Day72
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Paracetamol
Time frame: From Day1 to Day72
Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) of Paracetamol
Time frame: From Day4 to Day76
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Metformin
Time frame: From Day4 to Day76
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin
Time frame: From Day7 to Day84
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin
Time frame: From Day7 to Day84
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin
Time frame: From Day14 to Day69
Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504
Time frame: From Day1 to Day84
Time to Maximum Concentration (Tmax) of Metformin and Warfarin
Time frame: From Day1 to Day72
Terminal Half-life (t1/2) of Paracetamol
BrightGene Bio-Medical Technology Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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