The Second Affiliated Hospital of Anhui Medical University
Hefei, China
Location status: Recruiting
NCT Number: NCT07331389
The purpose of this study is to characterize the drug-drug intereaction of HDM1002 and metformin, empagliflozin, midazolam, valsartan, and warfarin in overweight/obese adult subjects. The safety and tolerability of HDM1002 with metformin, empagliflozin, midazolam, valsartan, and warfarin when given separately or together will also be evaluated
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Phase 1
Hefei, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered orally
Single dose; Administered orally
Single dose; Administered orally
Single dose; Administered orally
Single dose; Administered orally
Administered orally
Time frame: through study completion, an average of 11 weeks
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin:Area under the curve from time 0 hour to ∞
Time frame: through study completion, an average of 11 weeks
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Maximum observed concentration
Time frame: through study completion, an average of 11 weeks
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Area under the curve from time 0 to t hour
Time frame: through study completion, an average of 11 weeks
PK parameter of HDM1002 including Tmax, T1/2, CL/F, Vz/F, MRT, etc
Time frame: through study completion, an average of 11 weeks
Other PK parameters of metformin, empagliflozin, midazolam, valsartan, warfarin: Tmax, T1/2, CL/F, Vz/F, MRT, etc
Time frame: through study completion, an average of 11 weeks
Number of subjects reporting AEs
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Industry
A Phase I, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Drug-Drug Interaction of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin in Overweight/Obese Adult Chinese Subjects
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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