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

NCT06475872 | Completed Phase 1

• 1 other identifier: KMRI-BE-23021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Hypercholesterolemia; Combined Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Time to Maximum Plasma Concentration (Tmax)

  48 hours

• Half Life (t1/2)

  48 hours

• AUC∞

  48 hours

• AUCt/AUC∞(%)

  48 hours

• Dissolution pattern by comparative dissolution test of Rosuvastatin

  48 hours

Study Arms (2)

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.

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.

Drug: Crestor Tablet 5 mg

Interventions

Crecheck Tablet 2.5 mg DRUG

2 tablets orally once a day

Also known as: Rosuvastatin Calcium

Crecheck Tab

Crestor Tablet 5 mg DRUG

1 tablet orally once a day

Also known as: Rosuvastatin Calcium

Comparator

Eligibility Criteria

• Age: 19 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Seok Gyeong Medical Foundation Central Hospital

Gyeonggi-do, 15079, South Korea

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 26, 2024
• Study Start: November 20, 2023
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

KR (1)