CardiomyopathyPhase 1NCT07479641

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

A Phase 1 study testing Test formulation of HRS-1893 tablet and Reference formulation of HRS-1893 tablet in people with Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Cardiomyopathy
What is being tested?: Test formulation of HRS-1893 tablet and Reference formulation of HRS-1893 tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteChina
Study dates: 14 Apr 2026to 14 Sep 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

Subjects with suspected hypersensitivity to the investigational drug or any excipient;
The subject has a history of syncope;
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;
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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Hospital
Beijing, Beijing Municipality, 100730

Other trials in China

About this study

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

Conditions: Cardiomyopathy
Being tested: Test formulation of HRS-1893 tablet, Reference formulation of HRS-1893 tablet
Medical subject headings: Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Test formulation of HRS-1893 tabletDrug
Test formulation of HRS-1893 tablet, oral.
Reference formulation of HRS-1893 tabletDrug
Reference formulation of HRS-1893 tablet, oral.

Study groups in NCT07479641
Study group	Role	What they receive
HRS-1893 test formulation group	Experimental	Not described Receives: Drug: Test formulation of HRS-1893 tablet
HRS-1893 reference formulation group	Experimental	Not described Receives: Drug: Reference formulation of HRS-1893 tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak concentration (Cmax).
Primary Pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.
Measured: 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.
Measured: 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.
Measured: From Day 1 to Day 17.

Secondary outcomes (8)

Time to peak concentration (Tmax).
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.
Measured: From Day 1 to Day 17.
Elimination half-life (t1/2).
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.
Measured: From Day 1 to Day 17.
Apparent clearance (CL/F).
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.
Measured: 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.
Measured: 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.
Measured: From Day 1 to Day 21 ± 2.
12-Lead Electrocardiogram (ECG) QT Interval.
Safety and tolerability of different HRS-1893 formulations in healthy subjects.
Measured: From Day 1 to Day 21 ± 2.
Transthoracic echocardiogram (TTE) results.
Safety and tolerability of different HRS-1893 formulations in healthy subjects.
Measured: From Day 1 to Day 21 ± 2.
Vital signs results - blood pressure.
Safety and tolerability of different HRS-1893 formulations in healthy subjects.
Measured: From Day 1 to Day 21 ± 2.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 202614 Sep 2026

First posted18 Mar 2026
Study start14 Apr 2026
Primary completion14 Sep 2026
Study completion14 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CardiomyopathyStudies of the same condition, open and under way.
More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: This study is a single-center, randomized, open-label, crossover trial designed to evaluate the bioequivalence of two formulations of HRS-1893 tablets.
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07479641
Sponsor's protocol ID: HRS-1893-108
Status last verified: Sep 2026
First submitted: 11 Mar 2026
Last updated: 21 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
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Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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All Cardiomyopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Bioequivalence Study of Two Formulations of HRS-1893 Tablets in Healthy Participants
ClinicalTrials.gov ID: NCT07479641
Acronym / sponsor ID: HRS-1893-108
Conditions: Cardiomyopathy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 14 Apr 2026 (actual)
Primary completion: 14 Sep 2026 (actual)
Study completion: 14 Sep 2026 (actual)
First posted: 18 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: This study is a single-center, randomized, open-label, crossover trial designed to evaluate the bioequivalence of two formulations of HRS-1893 tablets.

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

Subjects with suspected hypersensitivity to the investigational drug or any excipient;
The subject has a history of syncope;
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;
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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Test formulation of HRS-1893 tabletTest formulation of HRS-1893 tablet, oral.	Drug	HRS-1893 test formulation group
Reference formulation of HRS-1893 tabletReference formulation of HRS-1893 tablet, oral.	Drug	HRS-1893 reference formulation group

Primary outcome

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

8 secondary outcomes

Time to peak concentration (Tmax).
Time frame: From Day 1 to Day 17.
Elimination half-life (t1/2).
Time frame: From Day 1 to Day 17.
Apparent clearance (CL/F).
Time frame: From Day 1 to Day 17.
Apparent volume of distribution (Vz/F).
Time frame: From Day 1 to Day 17.
Incidence and severity of any adverse events (AEs).
Time frame: From Day 1 to Day 21 ± 2.
12-Lead Electrocardiogram (ECG) QT Interval.
Time frame: From Day 1 to Day 21 ± 2.
Transthoracic echocardiogram (TTE) results.
Time frame: From Day 1 to Day 21 ± 2.
Vital signs results - blood pressure.
Time frame: From Day 1 to Day 21 ± 2.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Individual participant dataSharing planned: Undecided

Related trials for Cardiomyopathy

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Test formulation of HRS-1893 tablet and Reference formulation of HRS-1893 tablet in people with Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak concentration (Cmax). (time frame: From Day 1 to Day 17.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07479641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.