Health TrialsbyHealthPanel

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

ConditionCardiomyopathy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Test formulation of HRS-1893 tablet

    Drug

    Test formulation of HRS-1893 tablet, oral.

  • Reference formulation of HRS-1893 tablet

    Drug

    Reference formulation of HRS-1893 tablet, oral.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: HRS-1893 test formulation groupExperimental treatment 1 intervention
Group B: HRS-1893 reference formulation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Peak concentration (Cmax).

Primary Pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.

Time frame
From Day 1 to Day 17.
2

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.

Time frame
From Day 1 to Day 17.
3

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.

Time frame
From Day 1 to Day 17.

Secondary outcomes

1

Time to peak concentration (Tmax).

Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.

Time frame
From Day 1 to Day 17.
2

Elimination half-life (t1/2).

Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.

Time frame
From Day 1 to Day 17.
3

Apparent clearance (CL/F).

Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.

Time frame
From Day 1 to Day 17.
4

Apparent volume of distribution (Vz/F).

Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.

Time frame
From Day 1 to Day 17.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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