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
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.
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 →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.
Exclusion Criteria:
Individuals who have engaged in excessive alcohol consumption within one month before the start of the study (first dosing day)
Patients with the following conditions:
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
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
2 tablets orally once a day
Also known as: Rosuvastatin Calcium
1 tablet orally once a day
Also known as: Rosuvastatin Calcium
Area under the plasma concentration versus time curve (AUC)
Concentration of rosuvastatin in plasma
Time frame: 48 hours
Peak Plasma Concentration (Cmax)
Concentration of rosuvastatin in plasma
Time frame: 48 hours
Time to Maximum Plasma Concentration (Tmax)
Concentration of rosuvastatin in plasma
Time frame: 48 hours
Half Life (t1/2)
Concentration of rosuvastatin in plasma
Time frame: 48 hours
AUC∞
Concentration of rosuvastatin in plasma
Time frame: 48 hours
AUCt/AUC∞(%)
Concentration of rosuvastatin in plasma
Time frame: 48 hours
Dissolution pattern by comparative dissolution test of Rosuvastatin
Time frame: 48 hours
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Hanlim Pharm. Co., Ltd.