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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crecheck Tablet 2.5 mg | Drug | 2 tablets orally once a day |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
Patients with the following conditions:
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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seok Gyeong Medical Foundation Central Hospital | Gyeonggi-do | 15079 | South Korea |
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| Crestor Tablet 5 mg | Drug | 1 tablet orally once a day |
|
|
| 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 |
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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