HealthyPhase 1NCT07054255

Bioequivalence Study of Ranolazine Extended-release Tablets in Healthy Chinese Subjects

A Phase 1 study testing Test formulation (Ranolazine extended-release tablets) and Reference formulation (Ranolazine extended-release tablets) in people with Healthy, run by Haisco Pharmaceutical Group 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

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Trial summary

The present study was conducted with the objective of comparing the bioequivalence and safety of a single dose of ranolazine extended-release tablets (Test product) manufactured by Haisco Pharmaceutical Group Co., Ltd. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Test formulation (Ranolazine extended-release tablets) and Reference formulation (Ranolazine extended-release tablets)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteChina
Study dates: 6 Sep 2020to 21 Dec 2020
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy subjects aged 18 or older, both male and female, with an appropriate gender ratio;
Female subjects weight ≥ 45.0 kg and male subjects weight ≥ 50.0 kg, and BMI of 19 to 26 kg/m^2(inclusive);
Subjects who have no plans to conceive or donate sperm/eggs during the trial period until 3 months after the end of the trial and voluntarily adopt effective physical contraception measures.
Prior to the trial, a detailed understanding of the nature, significance, potential benefits, potential inconvenience, risks, and discomfort of the trial was obtained, and the subjects voluntarily participated in the clinical trial. The subject was able to communicate well with the researchers, comply with the requirements of the entire study, and signed a written informed consent form.

Who cannot join

Subjects who are known to be allergic to the investigational drug component Ranolazine (including excipients) or similar substances, or those with an allergic constitution (such as allergies to two or more drugs, food, or pollen) (consultation);
Subjects with a history of chronic or severe diseases or existing systemic diseases that may affect the research results, including those related to the blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental disorders, metabolic disorders, or any other conditions that may affect the research results (consultation);
Subjects who have undergone major surgery or suffered severe trauma within the first 3 months (90 days) of screening, or who have undergone surgery that may significantly affect the in vivo process or safety evaluation of the study drug (consultation);
Received vaccination within one month (30 days) before screening(consultation);
Used any prescription medication (such as antihypertensive drugs) within 1 month (30 days) before screening, or used any over-the-counter medication (vitamins, herbal medicines) within 2 weeks before screening (consultation);
Subjects who have participated in and used any clinical trial drug or medical device within 3 months (90 days) before the first administration, or those who plan to participate in other clinical trials during this study (consultation);

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Subjects who regularly drink alcohol within one month (30 days) before screening (drinking alcohol ≥ 3 times a week, and drinking 50 ° Baijiu ≥ 100 mL each time on average), or cannot abstain from alcohol during the test, or the alcohol breath test result is>0.000mg/mL (consultation, examination);
Subjects who have been addicted to smoking (more than 5 cigarettes per day or an equivalent amount of tobacco) for the past 3 months (90 days) prior to screening or who cannot stop using any tobacco products during the trial period (consultation);
Subjects who have lost blood/donated more than 400 mL (excluding physiological blood loss in females) within 2 months (60 days) prior to screening, or who have received blood transfusions/used blood products, or who plan to donate blood within 1 month (30 days) after the end of the trial (consultation);
On a daily within 2 weeks prior to screening,consuming excessive amounts of foods that affect metabolism, such as grapefruit or beverages containing grapefruit; Consuming excessive amounts of tea, coffee, chocolate, cola, or foods/beverages containing their main ingredients every day (averaging 8 or more cups per day, 200 mL per cup); Diets rich in xanthine, flavonoids, and other components (consultation);
Within 48 hours before the first administration, consume grapefruit or beverages containing grapefruit; Consuming tea, coffee, chocolate, cola, or foods/beverages containing their main ingredients; Consuming a diet rich in xanthine, flavonoids, and other components; Or those who engage in vigorous exercise (consultation);
Subjects with a history of drug abuse or positive results in urine drug abuse screening (consultation, examination);
Any positive subject in screening period virus serum blood examination (hepatitis B surface antigen, hepatitis C antibody, HIV antigen antibody, Treponema pallidum antibody);
During the screening period, if the physical examination, vital signs, electrocardiogram or laboratory test results are judged by clinical doctors to be abnormal and clinically significant, or if the QT interval is prolonged (female QT>440 ms or male QT>420 ms), or if fasting blood glucose exceeds the upper limit of normal values (examination);
Pregnant or lactating women, or those who test positive for pregnancy (consultation, examination);
Subjects who are prone to diarrhea, nausea, vomiting, bloating, or other gastrointestinal discomfort after drinking milk or dairy products, or who are prone to dizziness, headache, constipation, and nausea on a regular basis (consultation);
Subjects with a history of needle dizziness, blood dizziness, or intolerance to venipuncture blood collection (for consultation and examination);
Subjects with difficulty swallowing tablets/capsules (consultation);
Subjects with special dietary requirements (such as vegetarians) or those who cannot adhere to a uniform diet during the trial period (consultation);
Subjects who may not be able to cooperate with the completion of the study for other reasons, or the investigator may determine that they are not suitable for inclusion;

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongda Hospital, Southeast University
Nanjing, Jiangsu

Other trials in China

About this study

Official title: Bioequivalence and Safety Study of Ranolazine Extended-release Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Open-label, Single-dose, Cross-over Study

Conditions: Healthy
Being tested: Test formulation (Ranolazine extended-release tablets), Reference formulation (Ranolazine extended-release tablets)

What participants receive

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

Test formulation (Ranolazine extended-release tablets)Drug
A single oral dose of 500 mg, taken with 240mL of water
Reference formulation (Ranolazine extended-release tablets)Drug
A single oral dose of 500 mg, taken with 240mL of water

Study groups in NCT07054255
Study group	Role	What they receive
Test formulation	Experimental	Ranolazine sustained-release tablets, specification: 500 mg, Haisco Pharmaceutical Co., Ltd. Receives: Drug: Test formulation (Ranolazine extended-release tablets)
Reference formulation	Experimental	Ranolazine sustained-release tablets (Ranexa®), specification: 500 mg, Gilead Sciences, Inc. Receives: Drug: Reference formulation (Ranolazine extended-release tablets)

What is being measured

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

Cmax
The pharmacokinetic parameters of Ranolazine in plasma
Measured: From the start of administration to 48 hours post-dose
AUC(0-t)
The pharmacokinetic parameters of Ranolazine in plasma
Measured: From the start of administration to 48 hours post-dose
AUC(0-∞)
The pharmacokinetic parameters of Ranolazine in plasma
Measured: From the start of administration to 48 hours post-dose

Secondary outcomes (1)

AEs
The incidence and severity of AEs
Measured: From the time of signing ICF to the end of follow-up，up to 10 days

Timeline

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

6 Sep 202021 Dec 2020

First posted8 Jul 2025
Study start6 Sep 2020
Primary completion9 Nov 2020
Study completion21 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07054255
Sponsor's protocol ID: HSK-63-BE-2020
Status last verified: Jun 2025
First submitted: 27 Jun 2025
Last updated: 8 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Chen X, Li Y, Ma G. Bioequivalence and Safety Study of Ranolazine Extended-Release Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions: A Randomized, Open-Label, Single-Dose, Cross-Over, Comparative Pharmacokinetic Study. Clin Ther. 2026 Jan;48(1):88-94. doi: 10.1016/j.clinthera.2025.11.002. Epub 2025 Nov 25.
PubMed 41298182

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

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence and Safety Study of Ranolazine Extended-release Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Open-label, Single-dose, Cross-over Study
ClinicalTrials.gov ID: NCT07054255
Acronym / sponsor ID: HSK-63-BE-2020
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 6 Sep 2020 (actual)
Primary completion: 9 Nov 2020 (actual)
Study completion: 21 Dec 2020 (actual)
First posted: 8 Jul 2025 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test formulation	Experimental	Drug: Test formulation (Ranolazine extended-release tablets)Ranolazine sustained-release tablets, specification: 500 mg, Haisco Pharmaceutical Co., Ltd.
Reference formulation	Experimental	Drug: Reference formulation (Ranolazine extended-release tablets)Ranolazine sustained-release tablets (Ranexa®), specification: 500 mg, Gilead Sciences, Inc.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Healthy subjects aged 18 or older, both male and female, with an appropriate gender ratio;
Female subjects weight ≥ 45.0 kg and male subjects weight ≥ 50.0 kg, and BMI of 19 to 26 kg/m^2(inclusive);
Subjects who have no plans to conceive or donate sperm/eggs during the trial period until 3 months after the end of the trial and voluntarily adopt effective physical contraception measures.
Prior to the trial, a detailed understanding of the nature, significance, potential benefits, potential inconvenience, risks, and discomfort of the trial was obtained, and the subjects voluntarily participated in the clinical trial. The subject was able to communicate well with the researchers, comply with the requirements of the entire study, and signed a written informed consent form.

Key exclusion criteria (20 listed)

Subjects who are known to be allergic to the investigational drug component Ranolazine (including excipients) or similar substances, or those with an allergic constitution (such as allergies to two or more drugs, food, or pollen) (consultation);
Subjects with a history of chronic or severe diseases or existing systemic diseases that may affect the research results, including those related to the blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental disorders, metabolic disorders, or any other conditions that may affect the research results (consultation);
Subjects who have undergone major surgery or suffered severe trauma within the first 3 months (90 days) of screening, or who have undergone surgery that may significantly affect the in vivo process or safety evaluation of the study drug (consultation);
Received vaccination within one month (30 days) before screening(consultation);
Used any prescription medication (such as antihypertensive drugs) within 1 month (30 days) before screening, or used any over-the-counter medication (vitamins, herbal medicines) within 2 weeks before screening (consultation);

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
Test formulation (Ranolazine extended-release tablets)A single oral dose of 500 mg, taken with 240mL of water	Drug	Test formulation
Reference formulation (Ranolazine extended-release tablets)A single oral dose of 500 mg, taken with 240mL of water	Drug	Reference formulation

Primary outcome

Cmax
Time frame: From the start of administration to 48 hours post-dose
The pharmacokinetic parameters of Ranolazine in plasma
AUC(0-t)
Time frame: From the start of administration to 48 hours post-dose
The pharmacokinetic parameters of Ranolazine in plasma
AUC(0-∞)
Time frame: From the start of administration to 48 hours post-dose
The pharmacokinetic parameters of Ranolazine in plasma

1 secondary outcome

AEs
Time frame: From the time of signing ICF to the end of follow-up，up to 10 days

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 8 Jul 2025.
Derived from this study: PubMed 41298182Chen X, Li Y, Ma G. Bioequivalence and Safety Study of Ranolazine Extended-Release Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions: A Randomized, Open-Label, Single-Dose, Cross-Over, Comparative Pharmacokinetic Study. Clin Ther. 2026 Jan;48(1):88-94. doi: 10.1016/j.clinthera.2025.11.002. Epub 2025 Nov 25.

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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 4 inclusion and 20 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 8 Jul 2025. 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?

Cmax (time frame: From the start of administration to 48 hours post-dose). The study lists 3 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 NCT07054255, which also lists 1 linked publication.

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 8 Jul 2025.