A Phase 1 interventional study of HRS-1301 Tablet in Hyperlipidemias, sponsored by Shandong Suncadia Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 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
The primary objective of this study is to evaluate pharmacokinetics of HRS-1301 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
861 studies on the registry are indexed under Hyperlipidemias; 110 are open to participants now.
This study's enrollment of 36 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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment for oral medication.
Drug: HRS-1301 Tablet
HRS-1301 tablet, oral medication.
Maximum concentration (Cmax).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Area under the concentration-time curve from time zero to infinity (AUC0-inf).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Time of maximum concentration (Tmax).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Elimination half-life (t1/2).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Apparent clearance (CL/F).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Apparent volume of distribution (Vz/F).
Pharmacokinetic parameters of HRS-1301 in plasma.
Time frame: 0 hour to 8 days after dosing.
Cumulative drug excretion in urine (Ae,urine).
Pharmacokinetic parameters of HRS-1301 in urine.
Time frame: 0 hour to 6 days after dosing.
Cumulative drug excretion fraction in urine (fe,urine).
Pharmacokinetic parameters of HRS-1301 in urine.
Time frame: 0 hour to 6 days after dosing.
Incidence of adverse events (AEs).
Safety and tolerability.
Time frame: 0 hour to 8 days after dosing.
Incidence of serious adverse events (SAEs).
Safety and tolerability.
Time frame: 0 hour to 8 days after dosing.
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 drug tested here: HRS-1301
Shandong Suncadia Medicine Co., Ltd. →