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

NCT07479641 | Recruiting Phase 1

• 1 other identifier: HRS-1893-108
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Time to peak concentration (Tmax).

  From Day 1 to Day 17.

• Elimination half-life (t1/2).

  From Day 1 to Day 17.

• Apparent clearance (CL/F).

  From Day 1 to Day 17.

• Apparent volume of distribution (Vz/F).

  From Day 1 to Day 17.

• Incidence and severity of any adverse events (AEs).

  From Day 1 to Day 21 ± 2.

Study Arms (2)

HRS-1893 test formulation group

EXPERIMENTAL

Drug: Test formulation of HRS-1893 tablet

HRS-1893 reference formulation group

EXPERIMENTAL

Drug: Reference formulation of HRS-1893 tablet

Interventions

Test formulation of HRS-1893 tablet DRUG

Test formulation of HRS-1893 tablet, oral.

HRS-1893 test formulation group

Reference formulation of HRS-1893 tablet DRUG

Reference formulation of HRS-1893 tablet, oral.

HRS-1893 reference formulation group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects aged 18 to 55 years (inclusive), regardless of gender;
• 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;
• 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;
• No clinically significant abnormalities on the 12-lead ECG;
• The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.

You may not qualify if:

• Subjects with suspected hypersensitivity to the investigational drug or any excipient;
• The subject has a history of syncope;
• History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption;
• 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);
• 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;
• History of substance abuse;
• 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;
• 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.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Wenzheng Xiong

CONTACT

+86-0518-82342973; wenzheng.xiong.wx10@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a single-center, randomized, open-label, crossover trial designed to evaluate the bioequivalence of two formulations of HRS-1893 tablets.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 18, 2026
• Study Start: April 14, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)