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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Hypercholesterolemia; Combined Hyperlipidemia
• Intervention / Treatment: Drug: Crecheck Tablet 2.5 mg; Drug: Crestor Tablet 5 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 2 tablets orally once a day; Other Names: Rosuvastatin Calcium
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; 1 tablet orally once a day; Other Names: Rosuvastatin Calcium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration versus time curve (AUC)	Concentration of rosuvastatin in plasma	48 hours
Peak Plasma Concentration (Cmax)	Concentration of rosuvastatin in plasma	48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Actual): December 7, 2023
• Study Completion (Actual): December 7, 2023

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hypercholesterolemia; Hyperlipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Rosuvastatin Calcium; Calcium; Calcium, Dietary
• Other Study ID Numbers: KMRI-BE-23021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No