Peking University Third Hospital
Beijing, China
Location contact
Cui Cheng
PRINCIPAL_INVESTIGATOR
Dongyang Liu
PRINCIPAL_INVESTIGATOR
Xiaohong Wang
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06601517
The purpose of this study is to characterize the effect of HDM1002 on the PK of single dose of repaglinide, atorvastatin, digoxin and rosuvastatin in healthy adult subjects. The safety and tolerability of HDM1002 with repaglinide, atorvastatin, digoxin and rosuvastatin when given separately or together will also be evaluated.
Trial opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Phase 1
Beijing, China
Cui Cheng
PRINCIPAL_INVESTIGATOR
Dongyang Liu
PRINCIPAL_INVESTIGATOR
Xiaohong Wang
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose; Administered orally
Single dose; Administered orally
Single dose; Administered orally
Single dose; Administered orally
Administered orally
Time frame: Period 1 and Period 3: Day 1-Day 16
Pharmacokinetics (PK) parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 hour to ∞
Time frame: Period 1 and Period 3: Day 1-Day 16
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 to t hour
Time frame: Period 1 and Period 3: Day 1-Day 16
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Maximum observed concentration
Time frame: Period 1 and Period 3: Day 1-Day 16
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Time to maximum plasma concentration
Time frame: Period 1 and Period 3: Day 1-Day 16
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Half life
Time frame: Period 1 and Period 3: Day 1-Day 16
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent Clearance
Time frame: Period 1 and Period 3: Day 1-Day 16
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent volume of distribution
Time frame: Period 1 and Period 3: Day 1-Day 16, Period 2: Day 1-Day 35
Number of subjects reporting AEs
Contact information is provided by the study sponsor or research team.
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Industry
A Phase I, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of HDM1002 on the Pharmacokinetics of Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy and Overweight 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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