Drug Drug InteractionPhase 1NCT07692685

Pharmacokinetic Effect of Y-3 for Injection on Rosuvastatin Calcium Tablets in Healthy Participants

A Phase 1 study testing Use of rosuvastatin calcium tablet alone or combined with Y-3 for injection in people with Drug Drug Interaction and Pharmacokinetic Profiles, run by Neurodawn Pharmaceutical 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

Search all trials

Trial summary

The primary objective of this study is to evaluate the effect of Y-3 for injection on the pharmacokinetics of rosuvastatin calcium tablets (a sensitive BCRP probe substrate) in healthy participants, in order to assess the potential clinical drug-drug interaction. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Drug Drug Interaction, Pharmacokinetic Profiles, Safty
What is being tested?: Use of rosuvastatin calcium tablet alone or combined with Y-3 for injection
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: 7 May 2026to 4 Jun 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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily act as participants, and sign the informed consent form before the start of any study procedures;
Healthy male or female participants aged 18 ~ 50 years old (inclusive);
Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, Body Mass Index from19.0 to 26.0 kg/m2(inclusive).
The results of vital signs, physical examination, 12-lead electrocardiogram examination, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, kidney), chest X-ray and laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, four items before blood transfusion, fecal occult blood examination) are normal or judged by the investigator to be abnormal of no clinical significance;
Participants (including male participants) have no fertility plan and voluntarily take effective contraceptive measures (contraceptive measures other than contraceptive drugs during the trial) from the signing of informed consent until 3 months after the last administration of the Investigational Product, and have no sperm donation and egg donation plans;
Able to communicate well with the investigator, and understand and comply with the requirements of the trial.

Who cannot join

People with allergies: allergies to medicines, food, pollen, etc., or those who have a history of allergy to rosuvastatin calcium tablet, Y-3 for injection or any of components of above investigational products;
Those who have diseases or medical history that may affect drug absorption, distribution, metabolism, excretion or interpretation of safety data, or diseases or medical history that can reduce compliance, including but not limited to gastrointestinal, renal, hepatic, pulmonary, neurological, hematological, endocrine, tumor, immunologic, psychiatric or cardiovascular and cerebrovascular diseases (especially liver and kidney insufficiency, diabetes, hypoglycemia, bleeding tendency or cachexia, malignant hypertension, thrombocytopenia);
Those who with myopathy, myalgia or rhabdomyolysis;
Those who have undergone surgery within 6 months prior to the first use of the investigational products, or who have undergone surgeries that may affect the absorption, distribution, metabolism, or excretion of the drug (such as cholecystectomy), or those who plan to undergo surgery during the trial;
Participants with a history of needle or blood phobia, intolerance to venipuncture or intravenous administration, or difficulty in blood sampling.
Those who cannot follow the uniform diet (e.g., special requirements for diet, intolerance to standard meals, hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption).

Show all 21Show fewer

For patients with creatinine clearance <80 mL/min, creatinine clearance (mL/min) = [(140-age) × body weight (kg)]/[72×Scr(mg/dl)] or creatinine clearance (mL/min) = [(140-age) × body weight(kg)]/[0.818×Scr(μmol/L)], female study participants were × 0.85 according to the calculated results;
Those who have participated in or are participating in other clinical trials within 3 months before the first use of the investigational products (drug clinical trial is defined as the use of clinical investigational products), or planning to participate in other clinical trials during the trial period or within 1 month after the end of the trial, or those who do not come to participate in clinical trials in person;
Those who have donated blood (including component blood) or had heavy bleeding (>400 ml, except for blood loss during normal menstrual period in women) within 3 months before the first use of the investigational products, or received blood transfusion or used blood products, or planning to donate blood or blood components during the study or within 1 month after the end of the study;
Those who have had significant changes in diet or exercise habits within 3 months before the first use of the investigational products;
Those who smoke more than 5 cigarettes pre day within 3 months before the first use of the investigational products, or cannot stop using any tobacco products (including any smoking cessation products containing nicotine) within 48 hours before the first use of the investigational products and during the trial;
Those who have a history of drug abuse or drug use within 6 months before the first use of the investigational products, or who are positive for drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinolic acid, dimethylenedioxyamphetamine);
Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) per week within 3 months before the first use of the investigational products, or who cannot abstain from alcohol or stop using any diet containing alcohol within 48 hours before the first use of the investigational products and during the trial, or have a positive alcohol breath test result (greater than 0.0 mg/100 mL);
Those who consume excessive amounts of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months before the first use of the investigational products, or cannot stop using caffeine-rich foods or beverages (such as chocolate, coffee, tea, cola, etc.) within 48 hours before the first use of the investigational products and during the trial;
Those who have used any drug with potential interactions with the investigational products within 1 month before the first use of the investigational products;
Those who have been vaccinated within 1 month before the first use of the investigational products, or plan to receive any vaccine during the trial or within one week after the end of the trial;
Those who have used any prescription medicines, over-the-counter medicines, Chinese herbal medicines, health products and functional vitamins within 14 days before the first use of the investigational products;
Those who have one or more positive test results for hepatitis B surface antigen, hepatitis C virus antibody, HIV1/2 antigen/antibody and treponema pallidum antibody;
Females of childbearing potential who have had unprotected sex within 14 days prior to the first use of investigational products, or females who are pregnant or lactating, or who have a positive pregnancy test result;
Those who cannot stop ingesting grapefruit, dragon fruit, mango, lime, star fruit and other fruits or related products that affect metabolic enzymes within 48 hours before the first use of the investigational products and during the test;
Other conditions judged by the investigator to be inappropriate for enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui

Other trials in China

About this study

Official title: A Single-center, Open-label, Single-arm, Fixed-sequence, Self-controlled Study to Evaluate the Pharmacokinetic Effect of Y-3 for Injection on Rosuvastatin Calcium Tablets in Healthy Participants

The secondary objectives is to evaluate the effect of Y-3 for injection on the safety of rosuvastatin calcium tablets, and to evaluate the effect of rosuvastatin calcium tablets on the pharmacokinetics of Y-3 for injection in healthy participants.

Read the detailed description

This study is a single-center, open-label, single-arm, fixed-sequence, self-controlled study. A total of at least 20 participants (about half men and half women) will be will be enrolled and needed to complete in the study.On Days 1 and 11 of the trial, subjects shall orally take one tablet (10 mg) of rosuvastatin calcium on an fasted in the morning.From Day 5 to Day 14, 40 mg of Y-3 for Injection shall be administered via intravenous infusion once daily in the morning for 10 consecutive days (with an infusion duration of approximately 60 minutes). On Day 11, Y-3 for Injection (40mg) and one tablet (10mg) of rosuvastatin calcium shall be co-administered simultaneously.(with an interval of no more than 1 minute between the two administrations).

Conditions: Drug Drug Interaction, Pharmacokinetic Profiles, Safty
Being tested: Use of rosuvastatin calcium tablet alone or combined with Y-3 for injection
Keywords: Y-3 for injection, drug-drug interaction, BCRP transporter, rosuvastatin calcium tablet

What participants receive

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

Use of rosuvastatin calcium tablet alone or combined with Y-3 for injectionDrug
On Days 1 and 11 of the trial, subjects shall orally take one tablet (10 mg) of rosuvastatin calcium on an fasted in the morning.
From Day 5 to Day 14, 40 mg of Y-3 for Injection shall be administered via intravenous infusion once daily in the morning for 10 consecutive days . On Day 11, Y-3 for Injection (40mg) and one tablet (10mg) of rosuvastatin calcium shall be co-administered simultaneously.

Study groups in NCT07692685
Study group	Role	What they receive
Use of rosuvastatin calcium tablet alone or combined with Y-3 for injection	Other	Not described Receives: Drug: Use of rosuvastatin calcium tablet alone or combined with Y-3 for injection

What is being measured

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

AUC0-t of rosuvastatin
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Measured: On Day1-4 、 Day11-15 of observation period
AUC0-∞ of rosuvastatin
Area under the concentration-time curve from time 0 to infinity (extrapolated).
Measured: On Day1-4、Day11-15 of observation period.

Secondary outcomes (16)

Cmax of rosuvastatin
Measured: On Day1-4、Day11-15 of observation period.
Tmax of rosuvastatin
Measured: On Day1-4、Day11-15 of observation period.
t1/2 of rosuvastain
Measured: On Day1-4、Day11-15 of observation period.
λz of rosuvastain
Measured: On Day1-4、Day11-15 of observation period
AUC_%Extrap of rosuvastain
Measured: On Day1-4、Day11-15 of observation period.
Vz/F of rosuvastain
Measured: On Day1-4、Day11-15 of observation period.
CLz/F of rosuvastain
Measured: On Day1-4、Day11-15 of observation period.
AUC0-t of Y-3
Measured: On Day9-12 of observation period
Cmax of Y-3
Measured: On Day9-12 of observation period
Tmax of Y-3
Measured: On Day9-12 of observation period.
The Incidence of subject getting abnormal results of clinical adverse events after treatment.
Measured: The whole study period. Day -14 ~ Day 25.
The Incidence of subject getting abnormal results of vital signs after treatment
Measured: The whole study period. Day -14 ~ Day 25.
The Incidence of subject getting abnormal results of physical examinations after treatment.
Measured: The whole study period. Day -14 ~ Day 25.
The incidence of subject getting abnormal result of infusion-related reactions
Measured: The whole study period,Day-14~day25
The Incidence of subject getting abnormal results of laboratory tests after treatment.
Measured: The whole study period. Day -14 ~ Day 25.
The Incidence of subject getting abnormal results of 12-lead electrocardiograms after treatment.
Measured: The whole study period. Day -14 ~ Day 25.

Timeline

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

7 May 20264 Jun 2026

First posted9 Jul 2026
Study start7 May 2026
Primary completion4 Jun 2026
Study completion4 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Drug Drug InteractionStudies of the same condition, open and under way.
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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07692685
Sponsor's protocol ID: Y-3-LC-09
Status last verified: Jul 2026
First submitted: 2 Jul 2026
Last updated: 28 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Healthy Volunteer, Pharmacokinetics
RecruitingPhase 1
A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants
Healthy
Not yet recruitingPhase 1
LTG-321 - Itraconazole Drug-drug Interaction (DDI) Study
PK Drug-drug Interaction Study
Active, not recruitingPhase 1
A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer

All Drug Drug Interaction trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Open-label, Single-arm, Fixed-sequence, Self-controlled Study to Evaluate the Pharmacokinetic Effect of Y-3 for Injection on Rosuvastatin Calcium Tablets in Healthy Participants
ClinicalTrials.gov ID: NCT07692685
Acronym / sponsor ID: Y-3-LC-09
Conditions: Drug Drug Interaction, Pharmacokinetic Profiles, Safty
Keywords: Y-3 for injection, drug-drug interaction, BCRP transporter, rosuvastatin calcium tablet
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Neurodawn Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 7 May 2026 (actual)
Primary completion: 4 Jun 2026 (actual)
Study completion: 4 Jun 2026 (actual)
First posted: 9 Jul 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.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Use of rosuvastatin calcium tablet alone or combined with Y-3 for injection	Other	Drug: Use of rosuvastatin calcium tablet alone or combined with Y-3 for injection

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Participants fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily act as participants, and sign the informed consent form before the start of any study procedures;
Healthy male or female participants aged 18 ~ 50 years old (inclusive);
Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, Body Mass Index from19.0 to 26.0 kg/m2(inclusive).
The results of vital signs, physical examination, 12-lead electrocardiogram examination, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, kidney), chest X-ray and laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, four items before blood transfusion, fecal occult blood examination) are normal or judged by the investigator to be abnormal of no clinical significance;
Participants (including male participants) have no fertility plan and voluntarily take effective contraceptive measures (contraceptive measures other than contraceptive drugs during the trial) from the signing of informed consent until 3 months after the last administration of the Investigational Product, and have no sperm donation and egg donation plans;

Key exclusion criteria (21 listed)

People with allergies: allergies to medicines, food, pollen, etc., or those who have a history of allergy to rosuvastatin calcium tablet, Y-3 for injection or any of components of above investigational products;
Those who have diseases or medical history that may affect drug absorption, distribution, metabolism, excretion or interpretation of safety data, or diseases or medical history that can reduce compliance, including but not limited to gastrointestinal, renal, hepatic, pulmonary, neurological, hematological, endocrine, tumor, immunologic, psychiatric or cardiovascular and cerebrovascular diseases (especially liver and kidney insufficiency, diabetes, hypoglycemia, bleeding tendency or cachexia, malignant hypertension, thrombocytopenia);
Those who with myopathy, myalgia or rhabdomyolysis;
Those who have undergone surgery within 6 months prior to the first use of the investigational products, or who have undergone surgeries that may affect the absorption, distribution, metabolism, or excretion of the drug (such as cholecystectomy), or those who plan to undergo surgery during the trial;
Participants with a history of needle or blood phobia, intolerance to venipuncture or intravenous administration, or difficulty in blood sampling.

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
Use of rosuvastatin calcium tablet alone or combined with Y-3 for injectionOn Days 1 and 11 of the trial, subjects shall orally take one tablet (10 mg) of rosuvastatin calcium on an fasted in the morning. From Day 5 to Day 14, 40 mg of Y-3 for Injection shall be administered via intravenous infusion once daily in the morning for 10 consecutive days . On Day 11, Y-3 for Injection (40mg) and one tablet (10mg) of rosuvastatin calcium shall be co-administered simultaneously.	Drug	Use of rosuvastatin calcium tablet alone or combined with Y-3 for injection

Primary outcome

AUC0-t of rosuvastatin
Time frame: On Day1-4 、 Day11-15 of observation period
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
AUC0-∞ of rosuvastatin
Time frame: On Day1-4、Day11-15 of observation period.
Area under the concentration-time curve from time 0 to infinity (extrapolated).

16 secondary outcomes

Cmax of rosuvastatin
Time frame: On Day1-4、Day11-15 of observation period.
Tmax of rosuvastatin
Time frame: On Day1-4、Day11-15 of observation period.
t1/2 of rosuvastain
Time frame: On Day1-4、Day11-15 of observation period.
λz of rosuvastain
Time frame: On Day1-4、Day11-15 of observation period
AUC_%Extrap of rosuvastain
Time frame: On Day1-4、Day11-15 of observation period.
Vz/F of rosuvastain
Time frame: On Day1-4、Day11-15 of observation period.
CLz/F of rosuvastain
Time frame: On Day1-4、Day11-15 of observation period.
AUC0-t of Y-3
Time frame: On Day9-12 of observation period
Cmax of Y-3
Time frame: On Day9-12 of observation period
Tmax of Y-3
Time frame: On Day9-12 of observation period.
The Incidence of subject getting abnormal results of clinical adverse events after treatment.
Time frame: The whole study period. Day -14 ~ Day 25.
The Incidence of subject getting abnormal results of vital signs after treatment
Time frame: The whole study period. Day -14 ~ Day 25.
The Incidence of subject getting abnormal results of physical examinations after treatment.
Time frame: The whole study period. Day -14 ~ Day 25.
The incidence of subject getting abnormal result of infusion-related reactions
Time frame: The whole study period,Day-14~day25
The Incidence of subject getting abnormal results of laboratory tests after treatment.
Time frame: The whole study period. Day -14 ~ Day 25.
The Incidence of subject getting abnormal results of 12-lead electrocardiograms after treatment.
Time frame: The whole study period. Day -14 ~ Day 25.

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 28 Jul 2026.
Individual participant dataSharing planned: No

Related trials for Drug Drug Interaction

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Healthy Volunteer, Pharmacokinetics
RecruitingPhase 1
A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants
Healthy
Not yet recruitingPhase 1
LTG-321 - Itraconazole Drug-drug Interaction (DDI) Study
PK Drug-drug Interaction Study
Active, not recruitingPhase 1
A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer

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?

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 6 inclusion and 21 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 28 Jul 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?

AUC0-t of rosuvastatin (time frame: On Day1-4 、 Day11-15 of observation period). The study lists 2 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 NCT07692685.

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 28 Jul 2026.