CClinicalTrials.gg
CompletedNCT06475872Updated Jun 27, 2024

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 interventional study of Crecheck Tablet 2.5 mg and Crestor Tablet 5 mg in Primary Hypercholesterolemia and Combined Hyperlipidemia, sponsored by Hanlim Pharm. Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-27.

Sponsored by Hanlim Pharm. Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2023, registered Jun 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Primary Hypercholesterolemia
  • Combined Hyperlipidemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 36 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Hanlim Pharm. Co., Ltd. is the lead sponsor of 49 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Individuals aged 19 years or older at the time of screening
  2. 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)
  3. 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)
  4. Individuals with a Body Mass Index (BMI) between 18.0 and 30.0 (BMI calculation: weight (kg) / height (m)²)
  5. 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
  6. 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

Exclusion criteria

Exclusion Criteria:

  1. 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)
  2. 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)
  3. 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)
  4. 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)
  5. Individuals with a history of gastrointestinal surgery that may affect drug absorption
  6. 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
  7. Individuals with a history of mental illness
  8. 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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Crecheck Tab

    On the day of the visit, take 2 tablets of the test drug orally with 150 mL of water around 8 am.

    Drug: Crecheck Tablet 2.5 mg

  • Active comparator
    Comparator

    On the day of the visit, take 1 tablet of the comparator drug orally with 150 mL of water around 8 am.

    Drug: Crestor Tablet 5 mg

Interventions

  • DrugCrecheck Tablet 2.5 mg

    2 tablets orally once a day

    Also known as: Rosuvastatin Calcium

  • DrugCrestor Tablet 5 mg

    1 tablet orally once a day

    Also known as: Rosuvastatin Calcium

06

What researchers measure

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC)

    Concentration of rosuvastatin in plasma

    Time frame: 48 hours

  2. Peak Plasma Concentration (Cmax)

    Concentration of rosuvastatin in plasma

    Time frame: 48 hours

Secondary outcomes

  1. Time to Maximum Plasma Concentration (Tmax)

    Concentration of rosuvastatin in plasma

    Time frame: 48 hours

  2. Half Life (t1/2)

    Concentration of rosuvastatin in plasma

    Time frame: 48 hours

  3. AUC∞

    Concentration of rosuvastatin in plasma

    Time frame: 48 hours

  4. AUCt/AUC∞(%)

    Concentration of rosuvastatin in plasma

    Time frame: 48 hours

  5. Dissolution pattern by comparative dissolution test of Rosuvastatin

    Time frame: 48 hours

07

Study locations

1 site
  • Seok Gyeong Medical Foundation Central Hospital
    Gyeonggi-do, 15079, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06475872
Lead sponsor
Hanlim Pharm. Co., Ltd.
Responsible party
Sponsor
First posted
Jun 26, 2024
Start date
Nov 20, 2023
Primary completion
Dec 7, 2023
Completion
Dec 7, 2023
Last update
Jun 27, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion