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CompletedNCT07097831Updated Jan 9, 2026

A Clinical Trial of HRS-1301 on the Pharmacokinetics of Rosuvastatin Calcium Tablets in Healthy Subjects

A Phase 1 interventional study of HRS-1301 Tablets and Rosuvastatin Calcium Tablets in Hyperlipidemia, sponsored by Shandong Suncadia Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The study was designed to evaluate the pharmacokinetic effects of rosuvastatin calcium tablets after oral administration of HRS-1301 in healthy subjects.

02

Conditions studied

  • Hyperlipidemia

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03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 16 is below the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 86 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Males or females, aged 18-55 years (inclusive).
  2. At screening, 18.0 ≤ BMI ≤ 30 kg/m2 (inclusive), and body weight ≥ 50.0 kg and \<90.0 kg for males and ≥ 45.0 kg and \< 90.0 kg for females.
  3. Physical examination, vital signs, electrocardiogram, chest X-ray /CT, abdominal ultrasound, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, thyroid function) were normal or abnormal but of no clinical significance.
  4. The female subjects were not pregnant or lactating, and the results of pregnancy tests before the test were negative. Those who did not have unprotected sex within two weeks before screening; Female subjects of childbearing potential and men whose partners were women of childbearing age agreed to comply with relevant contraceptive requirements and had no sperm/egg donation plans.
  5. Participants were able to communicate well with the investigators, understand and comply with the requirements of the study, and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Previous medical history or current clinical diagnosis of cardiac, respiratory, endocrine, metabolic, cutaneous, infectious, malignant tumor, hematologic, neurological or psychiatric disorders, metabolic/functional disorders or other diseases.
  2. Gastrointestinal, hepatic, or renal disease, as judged by the investigator, or other conditions known to affect the absorption, distribution, metabolism, and excretion of the drug or to impair adherence.
  3. Patients with major trauma or surgery within 3 months before screening or planning to undergo surgery during the trial.
  4. Patients with specific allergic history (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergic to any drug, food), or known allergic to any ingredient in the study drug.
  5. Participants who had used any drugs (including prescription drugs, over-the-counter drugs, herbal medicines, dietary supplements, etc., except regular vitamins and occasional acetaminophen) within 2 weeks before screening, or within 5 half-life periods of the drugs (whichever was longer).
  6. Enrolled in a clinical trial of any drug or medical device within 3 months before screening or within 5 half-lives of the drug before screening, whichever is longer.
  7. Individuals who have donated ≥ 400 mL blood within 4 weeks before screening, have severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within 8 weeks before screening.
  8. Persons who are scheduled to receive live (attenuated) vaccine within 4 weeks before screening or during the course of the trial.
  9. Hepatitis B virus surface antigen, hepatitis C virus IgG antibody, anti-treponema pallidum antibody, human immunodeficiency virus antibody and antigen p24 positive during the screening period.
  10. Those with positive alcohol breath test and/or drug abuse screening test at baseline.
  11. A history of drug or substance abuse.
  12. Potential difficulty in blood collection, with a history of syncope.
  13. Investigators, research assistants, pharmacists, research coordinators, or others directly involved in the implementation of the protocol.
  14. Any factors considered by the investigator to be unsuitable for participation in the trial.
  15. Subjects voluntarily withdraw from the trial due to their own reasons.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Treatment Group

    Drug: HRS-1301 Tablets · Drug: Rosuvastatin Calcium Tablets

Interventions

  • DrugHRS-1301 Tablets

    HRS-1301 tablets.

  • DrugRosuvastatin Calcium Tablets

    Rosuvastatin calcium tablets.

06

What researchers measure

Primary outcomes

  1. Area under the curve from time 0 to time t (AUC0-t)

    Time frame: 0 to anticipated 15 days.

  2. Area under the curve from time 0 to time infinity (AUC0-∞)

    Time frame: 0 to anticipated 15 days.

  3. Maximum concentration (Cmax)

    Time frame: 0 to anticipated 15 days.

Secondary outcomes

  1. Time to reach maximum concentration (Tmax)

    Time frame: 0 to anticipated 15 days.

  2. Half-life (t1/2)

    Time frame: 0 to anticipated 15 days.

  3. Apparent clearance (CL/F)

    Time frame: 0 to anticipated 15 days.

  4. Adverse events (AEs)

    Time frame: Baseline up to 19 days.

07

Study locations

1 site
  • The Second Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215004, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07097831
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jul 31, 2025
Start date
Oct 9, 2025
Primary completion
Nov 7, 2025
Completion
Nov 7, 2025
Last update
Jan 9, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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