Primary HypercholesterolemiaPhase 1NCT06475872

Study to Evaluate the Bioequivalence of "Crecheck Tablet 2.5 mg (Rosuvastatin Calcium)" and "Crestor Tablet 5 mg (Rosuvastatin Calcium)" in Healthy Adult Subjects

A Phase 1 study testing Crecheck Tablet 2.5 mg and Crestor Tablet 5 mg in people with Primary Hypercholesterolemia and Combined Hyperlipidemia, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.

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

This clinical trial is an open, randomized, 2-group, 2-period, fasting, single-dose, crossover study to evaluate the bioequivalence of "Crecheck Tablet 2.5 mg (Rosuvastatin Calcium)" of Hanlim Pharm. Co., Ltd. and "Crestor Tablet 5 mg (Rosuvastatin Calcium)" of AstraZeneca Korea Co., Ltd. in healthy adult subjects. Read more about this study

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Primary Hypercholesterolemia, Combined Hyperlipidemia
What is being tested?: Crecheck Tablet 2.5 mg and Crestor Tablet 5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSouth Korea
Study dates: 20 Nov 2023to 7 Dec 2023
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 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Individuals aged 19 years or older at the time of screening
Individuals with no clinically significant congenital or chronic diseases and no pathological symptoms or findings based on medical examinations (such as EEG, ECG, chest and gastric endoscopy, or gastrointestinal radiology tests, if necessary)
Individuals deemed suitable for the study based on screening tests (e.g., hematology, blood chemistry, serology, and urinalysis) as determined by the principal investigator (or a designated sub-investigator)
Individuals with a Body Mass Index (BMI) between 18.0 and 30.0 (BMI calculation: weight (kg) / height (m)²)
Individuals who have received and understood a thorough explanation of the study's purpose, content, investigational drug characteristics, and potential adverse events, and have voluntarily decided to participate and agreed in writing to comply with the study requirements during the trial period
Individuals who agree to use medically recognized contraceptive methods* (excluding hormonal contraceptives) to avoid pregnancy from the first administration of the investigational drug until one week after the last administration * Medically recognized contraceptive methods: intrauterine devices (IUD, IUS), vasectomy, tubal ligation, and combined barrier methods (male condoms, female condoms, cervical caps, diaphragms, sponges, etc.), or if using spermicides, combined use of two or more barrier methods

Who cannot join

Individuals who have taken enzyme-inducing or inhibiting drugs such as barbiturates within 30 days before the start of the study (first dosing day) or medications that might interfere with the study within 10 days before the start of the study (first dosing day)
Individuals who have engaged in excessive alcohol consumption within one month before the start of the study (first dosing day)
For men, more than an average of 21 drinks per week
For women, more than an average of 14 drinks per week (One drink: 45 mL of distilled spirits or 360 mL of beer or 150 mL of wine)
Individuals who have participated in clinical trials (including bioequivalence studies) and received investigational drugs within six months before the start of the study (first dosing day)
Individuals who have donated whole blood within 8 weeks or donated blood components within 2 weeks before the start of the study (first dosing day)

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Individuals with a history of gastrointestinal surgery that may affect drug absorption
Patients with the following conditions:
Hypersensitivity to the components of this drug
Active liver disease, including unexplained persistent elevations in serum transaminases or serum transaminase levels exceeding three times the upper limit of normal
Myopathy
Concurrent use of cyclosporine
Severe renal impairment (creatinine clearance (CLcr) < 30 mL/min)
Pregnant or lactating women, and women of childbearing potential not using adequate contraceptive methods
Patients prone to myopathy/rhabdomyolysis (contraindicated when administered at a 40 mg dose of this drug)
Moderate renal impairment (creatinine clearance < 60 mL/min)
Hypothyroidism
A history or family history of hereditary muscle disorders
A history of muscle toxicity with other HMG-CoA reductase inhibitors or fibrates
Alcoholism
Situations where plasma concentrations may increase
Asian patients
Concurrent use of fibrates
Genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, since this product contains lactose
Individuals with a history of mental illness
Individuals deemed unsuitable for this clinical trial for reasons other than the above inclusion/exclusion criteria by the principal investigator (or a designated sub-investigator)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seok Gyeong Medical Foundation Central Hospital
Gyeonggi-do, 15079

Other trials in South Korea

About this study

Official title: Open, Randomized, 2-Group, 2-Period, Fasting, Single-Dose, Crossover Study to Evaluate the Bioequivalence of "Crecheck Tablet 2.5 mg (Rosuvastatin Calcium)" of Hanlim Pharm. Co., Ltd. and "Crestor Tablet 5 mg (Rosuvastatin Calcium)" of AstraZeneca Korea Co., Ltd. in Healthy Adult Subjects

Read the detailed description

This study is to compare and evaluate the safety and pharmacokinetic characteristics of Hanlim Pharm. Co., Ltd.'s "Crecheck Tablet 2.5 mg (Rosuvastatin Calcium)" as the test drug and AstraZeneca Korea Co., Ltd.'s "Crestor Tablet 5 mg (Rosuvastatin Calcium)" as the reference drug in healthy adults.

Conditions: Primary Hypercholesterolemia, Combined Hyperlipidemia
Being tested: Crecheck Tablet 2.5 mg, Crestor Tablet 5 mg

What participants receive

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

Crecheck Tablet 2.5 mgDrug
Also called Rosuvastatin Calcium
2 tablets orally once a day
Crestor Tablet 5 mgDrug
Also called Rosuvastatin Calcium
1 tablet orally once a day

Study groups in NCT06475872
Study group	Role	What they receive
Crecheck Tab	Experimental	On the day of the visit, take 2 tablets of the test drug orally with 150 mL of water around 8 am. Receives: Drug: Crecheck Tablet 2.5 mg
Comparator	Active comparator	On the day of the visit, take 1 tablet of the comparator drug orally with 150 mL of water around 8 am. Receives: Drug: Crestor Tablet 5 mg

What is being measured

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

Area under the plasma concentration versus time curve (AUC)
Concentration of rosuvastatin in plasma
Measured: 48 hours
Peak Plasma Concentration (Cmax)
Concentration of rosuvastatin in plasma
Measured: 48 hours

Secondary outcomes (5)

Time to Maximum Plasma Concentration (Tmax)
Concentration of rosuvastatin in plasma
Measured: 48 hours
Half Life (t1/2)
Concentration of rosuvastatin in plasma
Measured: 48 hours
AUC∞
Concentration of rosuvastatin in plasma
Measured: 48 hours
AUCt/AUC∞(%)
Concentration of rosuvastatin in plasma
Measured: 48 hours
Dissolution pattern by comparative dissolution test of Rosuvastatin
Measured: 48 hours

Timeline

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

20 Nov 20237 Dec 2023

First posted26 Jun 2024
Study start20 Nov 2023
Primary completion7 Dec 2023
Study completion7 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary HypercholesterolemiaStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06475872
Sponsor's protocol ID: KMRI-BE-23021
Status last verified: Jun 2024
First submitted: 17 Jun 2024
Last updated: 27 Jun 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: 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

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

All Primary Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open, Randomized, 2-Group, 2-Period, Fasting, Single-Dose, Crossover Study to Evaluate the Bioequivalence of "Crecheck Tablet 2.5 mg (Rosuvastatin Calcium)" of Hanlim Pharm. Co., Ltd. and "Crestor Tablet 5 mg (Rosuvastatin Calcium)" of AstraZeneca Korea Co., Ltd. in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT06475872
Acronym / sponsor ID: KMRI-BE-23021
Conditions: Primary Hypercholesterolemia, Combined Hyperlipidemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
Study start: 20 Nov 2023 (actual)
Primary completion: 7 Dec 2023 (actual)
Study completion: 7 Dec 2023 (actual)
First posted: 26 Jun 2024 (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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Crecheck Tab	Experimental	Drug: Crecheck Tablet 2.5 mgOn the day of the visit, take 2 tablets of the test drug orally with 150 mL of water around 8 am.
Comparator	Active comparator	Drug: Crestor Tablet 5 mgOn the day of the visit, take 1 tablet of the comparator drug orally with 150 mL of water around 8 am.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Individuals aged 19 years or older at the time of screening
Individuals with no clinically significant congenital or chronic diseases and no pathological symptoms or findings based on medical examinations (such as EEG, ECG, chest and gastric endoscopy, or gastrointestinal radiology tests, if necessary)
Individuals deemed suitable for the study based on screening tests (e.g., hematology, blood chemistry, serology, and urinalysis) as determined by the principal investigator (or a designated sub-investigator)
Individuals with a Body Mass Index (BMI) between 18.0 and 30.0 (BMI calculation: weight (kg) / height (m)²)
Individuals who have received and understood a thorough explanation of the study's purpose, content, investigational drug characteristics, and potential adverse events, and have voluntarily decided to participate and agreed in writing to comply with the study requirements during the trial period

Key exclusion criteria (26 listed)

Individuals who have taken enzyme-inducing or inhibiting drugs such as barbiturates within 30 days before the start of the study (first dosing day) or medications that might interfere with the study within 10 days before the start of the study (first dosing day)
Individuals who have engaged in excessive alcohol consumption within one month before the start of the study (first dosing day)
Individuals who have participated in clinical trials (including bioequivalence studies) and received investigational drugs within six months before the start of the study (first dosing day)
Individuals who have donated whole blood within 8 weeks or donated blood components within 2 weeks before the start of the study (first dosing day)
Individuals with a history of gastrointestinal surgery that may affect drug absorption

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
Crecheck Tablet 2.5 mgAlso: Rosuvastatin Calcium2 tablets orally once a day	Drug	Crecheck Tab
Crestor Tablet 5 mgAlso: Rosuvastatin Calcium1 tablet orally once a day	Drug	Comparator

Primary outcome

Area under the plasma concentration versus time curve (AUC)
Time frame: 48 hours
Concentration of rosuvastatin in plasma
Peak Plasma Concentration (Cmax)
Time frame: 48 hours
Concentration of rosuvastatin in plasma

5 secondary outcomes

Time to Maximum Plasma Concentration (Tmax)
Time frame: 48 hours
Half Life (t1/2)
Time frame: 48 hours
AUC∞
Time frame: 48 hours
AUCt/AUC∞(%)
Time frame: 48 hours
Dissolution pattern by comparative dissolution test of Rosuvastatin
Time frame: 48 hours

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 27 Jun 2024.

Related trials for Primary Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

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 26 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 27 Jun 2024. 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 South Korea. 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?

Area under the plasma concentration versus time curve (AUC) (time frame: 48 hours). 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 NCT06475872.

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 27 Jun 2024.