Compare two formulations of HRS-1893 tablets in healthy adults

A Bioequivalence Study of Two Formulations of HRS-1893 Tablets in Healthy Participants

This will test whether two HRS-1893 tablet formulations produce similar blood levels and are safe in healthy adult volunteers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07479641 on ClinicalTrials.gov

What this trial studies

This Phase 1 bioequivalence study compares a test and a reference formulation of HRS-1893 in healthy adults aged 18 to 55. Eligible participants must meet specified BMI and weight ranges and have no clinically significant findings on physical exam, labs, or ECG. Subjects will receive the formulations under controlled conditions with blood sampling to compare pharmacokinetic profiles, and safety and tolerability will be monitored. The sponsor is Shandong Suncadia Medicine Co., Ltd., and the study is conducted at Beijing Hospital.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18–55 who meet the BMI and weight requirements and have no clinically significant medical, ECG, or laboratory abnormalities.

Not a fit: People with active cardiomyopathy, uncontrolled blood pressure, a history of syncope, known hypersensitivity to the drug or excipients, or who fail the screening criteria are unlikely to gain direct benefit from participation.

Why it matters

Potential benefit: If the formulations are equivalent, the alternate formulation could be used interchangeably with the reference product, which may improve availability or manufacturing flexibility for patients.

How similar studies have performed: Bioequivalence studies comparing pharmacokinetic profiles in healthy volunteers are a well-established and commonly successful method for demonstrating formulation interchangeability.

Eligibility criteria

Inclusion Criteria:

1. Subjects aged 18 to 55 years (inclusive), regardless of gender;
2. Body mass index (BMI) between 19 and 28 kg/m² (inclusive), with body weight ≥ 50.0 kg and \< 90.0 kg for men, and ≥ 45.0 kg and \< 90.0 kg for women;
3. No abnormalities of clinical significance are found upon comprehensive physical examination and laboratory tests, or only minor abnormalities that are deemed by the investigator not to affect the subject's eligibility for enrollment;
4. No clinically significant abnormalities on the 12-lead ECG;
5. The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.

Exclusion Criteria:

1. Subjects with suspected hypersensitivity to the investigational drug or any excipient;
2. The subject has a history of syncope;
3. Exclusion due to blood pressure: Systolic Blood Pressure (SBP) \>140 mmHg or \<90 mmHg; OR Diastolic Blood Pressure (DBP) \>90 mmHg or \<60 mmHg, as determined by the investigator to be clinically significant;
4. History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption;
5. A positive result in any one of the following infectious disease screening tests during the screening period: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody (syphilis), or human immunodeficiency virus antibody/antigen (HIV-Ab/Ag);
6. Subjects who meet any of the following criteria will be excluded: a. Smoking: Average daily cigarette consumption of more than 5 cigarettes within the 4 weeks prior to screening; b. Alcohol: Average daily alcohol intake exceeding 15 g within one week prior to screening (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or 50 mL of low-alcohol spirits); c. Non-compliance: Inability or unwillingness to abstain from smoking, alcohol, and caffeine-containing foods or beverages during the screening period and the entire study duration; d. Diet: Have special dietary requirements, cannot comply with the standardized diet provided in the study, or have a history of substance abuse;
7. History of substance abuse;
8. Use of any prescription drugs, over-the-counter medications, or Chinese herbal medicines within 1 month prior to dosing, or the use of any drug within 5 half-lives prior to screening (whichever is longer). Additionally, subjects who plan to take any non-study medications during the trial period will be excluded;
9. Any other circumstances that, in the investigator's judgment, make the subject unsuitable for participation in the trial. This includes physiological or psychological conditions that may increase the trial risk, affect the subject's protocol compliance, or impact the subject's ability to complete the study.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Wenzheng Xiong

Conditions Cardiomyopathy