An Open, Fixed-sequence, Self-controlled Pharmacokinetic Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects

Shandong Suncadia Medicine Co., Ltd.1 site in 1 country40 target enrollmentDecember 8, 2025

InterventionsHRS-7535 Tablets Rosuvastatin Calcium Tablets Omeprazole Enteric-coated Capsules Digoxin Tablets Paracetamol Tablets

DrugsHRS-7535 Tablets Paracetamol Tablets Digoxin Tablets Rosuvastatin Calcium Tablets Omeprazole Enteric-coated Capsules

Overview

Phase: Phase 1
Intervention: HRS-7535 Tablets
Conditions: Not specified
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Enrollment: 40
Locations: 1
Primary Endpoint: Maximum concentration (Cmax)
Status: Completed
Last Updated: 17 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is an open-label, fixed-sequence, self-controlled Phase I clinical trial conducted among obese or overweight subjects, with a planned enrollment of 40 adult subjects.

Registry

clinicaltrials.gov

Start Date

December 8, 2025

End Date

March 8, 2026

Last Updated

17 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol;
•Males or females aged 18-50 years (inclusive);
•Weight ≥ 50.0 kg and \<100.0 kg, and body mass index (BMI) ≥26.0 kg/m2;
•Male subjects who are female with fertility or whose partners are female with fertility must have no plans to have children or donate sperm/eggs from the date of signing the informed consent form until one month after the last medication use, and voluntarily take effective contraceptive measures (including for their partners).

Exclusion Criteria

•Those with a history of drug or food allergies, or those with an allergic constitution;
•History of inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of multiple other factors that affect drug administration and absorption;
•History of diabetes (except gestational diabetes);
•Those with a history of severe hypoglycemia;
•There is a history of clinical gastric emptying abnormalities (such as gastric outlet obstruction) and severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcers) in the past;
•Those with a history or family history of medullary thyroid carcinoma, multiple endocrine adenomatosis type 2, acute or chronic pancreatitis, symptomatic gallbladder diseases or cholestasis;
•Any malignant tumor of the organ system has occurred within 5 years, regardless of whether there is evidence of local recurrence or metastasis. Local basal cell carcinoma of the skin, cervical carcinoma in situ and prostate carcinoma in situ are excluded;
•Those who have undergone any surgery within the six months prior to screening;
•Severe cardiovascular and cerebrovascular diseases have occurred within 6 months prior to screening, including but not limited to: heart failure (NYHA grade II-IV), angina pectoris, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or coronary artery bypass grafting or percutaneous coronary intervention, etc. And/or planned to undergo coronary, carotid or peripheral artery revascularization at the time of screening;
•Those who frequently consumed alcohol within the six months prior to the screening, that is, those who consumed more than 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of 40% alcohol spirits, or 100 mL of wine), and who could not stop using any alcoholic products during the trial period, and whose breath test for alcohol was positive;

Arms & Interventions

Oral Medication Group

Intervention: HRS-7535 Tablets

Oral Medication Group

Intervention: Rosuvastatin Calcium Tablets

Oral Medication Group

Intervention: Omeprazole Enteric-coated Capsules

Oral Medication Group

Intervention: Digoxin Tablets

Oral Medication Group

Intervention: Paracetamol Tablets

Outcomes

Primary Outcomes

Maximum concentration (Cmax)

Time Frame: 63 days.

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last)

Time Frame: 63 days.

Area under the concentration-time curve from time zero to infinity (AUC0-inf)

Time Frame: 63 days.

Secondary Outcomes

Elimination half-life (t1/2)(63 days.)
Apparent clearance (CL/F)(63 days.)
Apparent volume of distribution (Vz/F)(63 days.)
Time of maximum concentration (Tmax)(63 days.)
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau)(63 days.)
Incidence of adverse events (AEs)(70 days.)
Incidence of serious adverse events (SAEs)(70 days.)