A Phase 1 interventional study of HRS-1301 Tablets and Atorvastatin Calcium Tablets in Hyperlipidemias, 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 2026-09-30.
Sponsored by Shandong Suncadia Medicine Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 1, Interventional, and Treatment
This phase I study in healthy participants aims to assess the pharmacokinetics of midazolam and atorvastatin when administered alone and in combination with HRS-1301, and to assess the safety of HRS-1301 when administered alone and in combination with midazolam or atorvastatin.
861 studies on the registry are indexed under Hyperlipidemias; 110 are open to participants now.
This study's enrollment of 16 is below the median of 88 across 735 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 87 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HRS-1301 tablets and Midazolam oral solution or Atorvastatin Calcium tablets, specified dose on specified days.
Drug: HRS-1301 Tablets · Drug: Atorvastatin Calcium Tablets · Drug: Midazolam oral solution
HRS-1301 tablets.
Atorvastatin Calcium tablets.
Midazolam oral solution.
Maximum observed plasma concentration (Cmax)
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 15 days.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 15 days.
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 15 days.
Maximum observed plasma concentration (Cmax)
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 18 days.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 18 days.
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 18 days.
Time to reach maximum observed concentration (Tmax)
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 15 days.
Terminal elimination half-life (t1/2)
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 15 days.
Apparent clearance (CL/F)
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 15 days.
Apparent volume of distribution (Vz/F)
Plasma pharmacokinetics (PK) parameters of Midazolam 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 15 days.
Maximum observed plasma concentration (Cmax)
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
Time frame: Up to 15 days.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
Time frame: Up to 15 days.
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
Time frame: Up to 15 days.
Apparent volume of distribution (Vz/F)
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 18 days.
Apparent clearance (CL/F)
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 18 days.
Time to reach maximum observed concentration (Tmax)
Plasma pharmacokinetics (PK) parameters of Atorvastatin 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 18 days.
Terminal elimination half-life (t1/2)
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Time frame: Up to 18 days.
Maximum observed plasma concentration (Cmax)
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
Time frame: Up to 18 days.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
Time frame: Up to 18 days.
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
Time frame: Up to 18 days.
Incidence and severity of adverse events (AEs)
Safety and Tolerability.
Time frame: Up to 22 days.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: HRS-1301 · Atorvastatin
Shandong Suncadia Medicine Co., Ltd. →