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

This study will investigate the bioequivalence between two formulations of HRS-1893 tablets. Safety and tolerability will also be assessed.

Study Overview

• Status: Recruiting
• Conditions: Cardiomyopathy
• Intervention / Treatment: Drug: Test formulation of HRS-1893 tablet; Drug: Reference formulation of HRS-1893 tablet

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wenzheng Xiong; Phone Number: +86-0518-82342973; Email: wenzheng.xiong.wx10@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Recruiting
      • Beijing Hospital
      • Principal Investigator: Xin Wang
      • Contact: Xin Wang; Phone Number: +86-010-58115037; Email: wangxinannie@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-1893 test formulation group	Drug: Test formulation of HRS-1893 tablet; Test formulation of HRS-1893 tablet, oral.
Experimental: HRS-1893 reference formulation group	Drug: Reference formulation of HRS-1893 tablet; Reference formulation of HRS-1893 tablet, oral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak concentration (Cmax).	Primary Pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.	From Day 1 to Day 17.
Area under the plasma concentration - time curve from Time 0 to the last quantifiable time point (AUC0-t).	Primary Pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.	From Day 1 to Day 17.
Area under the plasma concentration - time curve from Time 0 to infinity (AUC0-∞).	Primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.	From Day 1 to Day 17.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to peak concentration (Tmax).	Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.	From Day 1 to Day 17.
Elimination half-life (t1/2).	Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.	From Day 1 to Day 17.
Apparent clearance (CL/F).	Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.	From Day 1 to Day 17.
Apparent volume of distribution (Vz/F).	Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.	From Day 1 to Day 17.
Incidence and severity of any adverse events (AEs).	Safety and tolerability of different HRS-1893 formulations in healthy subjects.	From Day 1 to Day 21 ± 2.
12-Lead Electrocardiogram (ECG) QT Interval.	Safety and tolerability of different HRS-1893 formulations in healthy subjects.	From Day 1 to Day 21 ± 2.
Transthoracic echocardiogram (TTE) results.	Safety and tolerability of different HRS-1893 formulations in healthy subjects.	From Day 1 to Day 21 ± 2.
Vital signs results - blood pressure.	Safety and tolerability of different HRS-1893 formulations in healthy subjects.	From Day 1 to Day 21 ± 2.

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 15, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies
• Other Study ID Numbers: HRS-1893-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No