BioequivalencePhase 1NCT06830954
Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants
A Phase 1 study testing Group A and Reference Group in people with Bioequivalence, run by Shenzhen Salubris Pharmaceuticals Co., Ltd..
Trial summary
The purpose of this study is to evaluate the bioequivalence of the test preparation (Fluvastatin sodium extended release tablet, 80 mg) manufactured by Shenzhen Salubris Pharmaceuticals Co., Ltd. and the reference preparation (80 mg) manufactured by Beijing Novartis Pharma Co., Ltd. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Group A and Reference Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants have fully understood the trial's objectives, procedures, and potential adverse effects, and voluntarily signed informed consent form prior to the trial.
- Participants are able to communicate effectively with the investigator and comply with the protocol requirements to complete the trial.
- Healthy male or female adults aged 18 to 65 years (inclusive).
- Body weight ≥50 kg for male participants and ≥45 kg for female participants at screening, with a body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive; BMI = body weight ÷ height2).
- No abnormalities or only slight abnormalities not clinically significant of tests/examinations as judged by the investigator. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatine kinase (CK) must not exceed the upper limit of the normal reference range.
- Participants or their partners must not have any pregnancy plans during the study and for three months after the last administration of the investigational drug. They must voluntarily take effective contraceptive measures (the use of contraceptive medications is prohibited during the study) to avoid pregnancy for themselves or their partners, and participants must not donate sperm or eggs (ovum and oocytes) for reproductive or assisted reproductive purposes.
Who cannot join
- Pregnant or lactating women, or women of child-bearing potential (WOCBP) with a positive pregnancy test at screening.
- Participants who have a history of clinically significant acute allergy to drug or food within two weeks prior to screening, or have an allergic constitution (e.g., allergy to two or more drugs, food, or pollens), or have a history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or have possible or definite allergy, hypersensitivity or clinically significant reactions to investigational drugs or excipients judged by the investigator.
- Participants with any disease (e.g., acute gastritis, peptic ulcer, anaphylactoid purpura, lupus erythematosus, etc.) or history (e.g., haemorrhage intracranial, hemorrhage intraocular, haemophilia, angiohaemophilia, etc.) that may change or aggravate haemorrhagic diathesis as judged by the investigator.
- Participants with a positive result for any of the following tests: hepatitis B surface antigen test, hepatitis C antibody test, HIV antibody test, and treponema pallidum antibody test.
- Drug abuse, alcohol abuse, or tobacco addiction:
- Participants with a history of drug abuse, or a positive result for drug abuse test at screening; Participants with an average alcohol consumption of more than 14 units per week (1 unit ≈ 17.7 mL of ethanol, i.e., 1 unit ≈ 360 mL of beer with 5% alcohol content or 45 mL of spirit with 40% alcohol content or 150 mL of wine with 12% alcohol content) within 3 months prior to screening, or with a positive result for breath alcohol test at screening, or those who could not completely stop consuming alcohol-containing food or beverages during the study; Participants with an average tobacco consumption of more than 5 cigarettes per day within 3 months prior to screening, or those who could not completely stop consuming tobacco products during the study.
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- •Subjects who used any of the following food, medications, or treatments prior to the first dose: Used any drugs that inhibit or induce liver drug metabolism (e.g., inducers such as barbiturates, carbamazepine, phenytoin, rifampicin; inhibitors such as SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within four weeks prior to the first dose.; Female participants who have used long-acting estrogen or progestin injections or implants within six months prior to screening; Used any prescription drugs, Chinese herbal medicines, or food supplements (including vitamins, health-care food, etc.) within 2 weeks prior to the first dose; Habitual consumption of grapefruit or grapefruit juice-containing products within 1 week prior to screening, or unwillingness to abstain from grapefruit-containing foods or beverages from 48 hours before dosing of the first period to 48 hours after dosing of the fourth period; Consumption of xanthine-rich foods or beverages (e.g., chocolate, cocoa beans, coffee) within 48 hours prior to the first dose, or unwillingness to abstain from xanthine-rich foods or beverages from 48 hours before the dosing of first period to 48 hours after dosing of the fourth period.
- Consumed tea, coffee, and/or foods or beverages containing caffeine within 48 hours prior to the first dose, or do not agree to refrain from consuming tea, coffee, and/or foods or beverages containing caffeine from 48 hours before dosing of the first period until 48 hours after dosing of the fourth period.
- Participants who participated or are participating in any interventional clinical study (including investigational drug or vaccine, and other clinical studies of fluvastatin or other cohorts of this study) and received drugs within 3 months prior to screening.
- Participants with dysphagia or special dietary requirements who cannot adhere to a standardized diet.
- Participants who received live vaccines, attenuated vaccines, or vaccines containing any live viral components within 3 months prior to screening, or those who plan to receive any of these vaccines during the study.
- Participants who experienced blood donation (including component blood donation) or blood loss ≥ 400 mL within 3 months prior to screening; or blood donation (including component blood donation) or blood loss ≥ 200 mL or blood transfusion within 1 month prior to screening; or those who plan to donate blood or blood components during the study or within 1 month after the end of study.
- Participants who experienced major trauma or had a major surgery (e.g., surgery requiring general anesthesia) within 3 months prior to screening, or those who plan to undergo a surgery (except for surgery requiring local anesthesia) during the study or within 3 months after the end of study.
- Participants who have difficulty veins or cannot bear multiple venipunctures, or those with a history of clinically significant fear of needles or hemophobia as judged by the investigator.
- Participants with other diseases or medical history that are clinically significant or may prevent the subjects from completing this study as judged by the investigator (including various systems such as respiratory, cardiovascular, digestive, genitourinary, hematologic, endocrine, neurological, and psychiatric systems, and malignant tumors), or other diseases or medical history that may significantly alter drug absorption, metabolism, or elimination (e.g., history of gastrointestinal surgery, renal surgery, or cholecystectomy, which may affect the in vivo disposition of the drug), or infectious diseases.
- Participants with a history of musculoskeletal and connective tissue disorders (e.g., myalgia, myopathy) or a history of hereditary muscle diseases or rhabdomyolysis.
- Participants who are not suitable for participating in this study for any other reasons as judged by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to evaluate the bioequivalence of the test preparation (Fluvastatin sodium extended release tablet, 80 mg) manufactured by Shenzhen Salubris Pharmaceuticals Co., Ltd. and the reference preparation (80 mg) manufactured by Beijing Novartis Pharma Co., Ltd. in healthy participants under fasting and fed conditions.
Read the detailed description
This is a single center, open-label, randomized, two-sequence, four-period, crossover bioequivalence study.
The study is mainly divided into two stages: screening period (2 weeks) and treatment period (4 weeks). Washout time is 7 days.
- Conditions
- Bioequivalence
- Being tested
- Group A, Reference Group
- Keywords
- Fluvastatin, Pharmacokinetics, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ADrug
Also called Test Group
Drug: Fluvastatin sodium extended release tablet, 80 mg Period 1 and 3, the participants randomly received single oral dose of test drug ( Fluvastatin sodium extended release tablet 80 mg). Period 2 and 4, the participants randomly received single oral dose of reference drug ( Fluvastatin sodium extended release tablet 80 mg).
Reference GroupDrug
Drug: Fluvastatin sodium extended release tablet, 80 mg Period 1 and 3, the participants randomly received single oral dose of reference drug ( Fluvastatin sodium extended release tablet 80 mg). Period 2 and 4, the participants randomly received single oral dose of test drug ( Fluvastatin sodium extended release tablet 80 mg).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Drug: Fluvastatin sodium extended release tablet, 80 mg The participants randomly received single oral dose of Fluvastatin sodium extended release tablet 80 mg. Receives: Drug: Group A; Drug: Reference Group |
| Group B | Active comparator | Drug: Fluvastatin sodium extended release tablet, 80 mg The participants randomly received single oral dose of Fluvastatin sodium extended release tablet 80 mg. Receives: Drug: Group A; Drug: Reference Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Observed maximum plasma concentration (Cmax)
Measured: up to Day 24
AUC0-t
Plasma concentration-time curve from time zero extrapolated to the time of last quantifiable concentration (AUC0-t)
Measured: up to Day 24
AUC0-∞
Plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Measured: up to Day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- two-sequence, four-period
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongying Yang, MD, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830954
- Sponsor's protocol ID
- SAL-138-BE01
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants
- ClinicalTrials.gov ID
- NCT06830954
- Acronym / sponsor ID
- SAL-138-BE01
- Conditions
- Bioequivalence
- Keywords
- Fluvastatin, Pharmacokinetics, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Feb 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.
The purpose of this study is to evaluate the bioequivalence of the test preparation (Fluvastatin sodium extended release tablet, 80 mg) manufactured by Shenzhen Salubris Pharmaceuticals Co., Ltd. and the reference preparation (80 mg) manufactured by Beijing Novartis Pharma Co., Ltd. in healthy participants under fasting and fed conditions.
Detailed description
This is a single center, open-label, randomized, two-sequence, four-period, crossover bioequivalence study.
The study is mainly divided into two stages: screening period (2 weeks) and treatment period (4 weeks). Washout time is 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-sequence, four-period
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Group A, Drug: Reference GroupDrug: Fluvastatin sodium extended release tablet, 80 mg The participants randomly received single oral dose of Fluvastatin sodium extended release tablet 80 mg. |
| Group B | Active comparator | Drug: Group A, Drug: Reference GroupDrug: Fluvastatin sodium extended release tablet, 80 mg The participants randomly received single oral dose of Fluvastatin sodium extended release tablet 80 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants have fully understood the trial's objectives, procedures, and potential adverse effects, and voluntarily signed informed consent form prior to the trial.
- Participants are able to communicate effectively with the investigator and comply with the protocol requirements to complete the trial.
- Healthy male or female adults aged 18 to 65 years (inclusive).
- Body weight ≥50 kg for male participants and ≥45 kg for female participants at screening, with a body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive; BMI = body weight ÷ height2).
- No abnormalities or only slight abnormalities not clinically significant of tests/examinations as judged by the investigator. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatine kinase (CK) must not exceed the upper limit of the normal reference range.
Key exclusion criteria (17 listed)
- Pregnant or lactating women, or women of child-bearing potential (WOCBP) with a positive pregnancy test at screening.
- Participants who have a history of clinically significant acute allergy to drug or food within two weeks prior to screening, or have an allergic constitution (e.g., allergy to two or more drugs, food, or pollens), or have a history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or have possible or definite allergy, hypersensitivity or clinically significant reactions to investigational drugs or excipients judged by the investigator.
- Participants with any disease (e.g., acute gastritis, peptic ulcer, anaphylactoid purpura, lupus erythematosus, etc.) or history (e.g., haemorrhage intracranial, hemorrhage intraocular, haemophilia, angiohaemophilia, etc.) that may change or aggravate haemorrhagic diathesis as judged by the investigator.
- Participants with a positive result for any of the following tests: hepatitis B surface antigen test, hepatitis C antibody test, HIV antibody test, and treponema pallidum antibody test.
- Drug abuse, alcohol abuse, or tobacco addiction:
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 |
|---|---|---|
| Group AAlso: Test GroupDrug: Fluvastatin sodium extended release tablet, 80 mg Period 1 and 3, the participants randomly received single oral dose of test drug ( Fluvastatin sodium extended release tablet 80 mg). Period 2 and 4, the participants randomly received single oral dose of reference drug ( Fluvastatin sodium extended release tablet 80 mg). | Drug | Group A, Group B |
| Reference GroupDrug: Fluvastatin sodium extended release tablet, 80 mg Period 1 and 3, the participants randomly received single oral dose of reference drug ( Fluvastatin sodium extended release tablet 80 mg). Period 2 and 4, the participants randomly received single oral dose of test drug ( Fluvastatin sodium extended release tablet 80 mg). | Drug | Group A, Group B |
Primary outcome
Cmax
Time frame: up to Day 24
Observed maximum plasma concentration (Cmax)
AUC0-t
Time frame: up to Day 24
Plasma concentration-time curve from time zero extrapolated to the time of last quantifiable concentration (AUC0-t)
AUC0-∞
Time frame: up to Day 24
Plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Hongying Yang, MD principal investigator
Shenzhen People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group A and Reference Group in people with Bioequivalence, run by Shenzhen Salubris Pharmaceuticals Co., Ltd..
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 17 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: opening soon, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongying Yang, MD (0755-22942636, yanghy0119@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: up to Day 24). 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?
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 17 Feb 2025.