Phase 1Completed
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
- Sponsor
- Hanlim Pharm. Co., Ltd. (Industry)
- Enrolment
- 36 enrolled
- Conditions
- Primary Hypercholesterolemia; Combined Hyperlipidemia
- Interventions
- Crecheck Tablet 2.5 mg; Crestor Tablet 5 mg
- Ages
- adults, older adults
- Registry
- NCT06475872
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Area under the plasma concentration versus time curve (AUC)
- Peak Plasma Concentration (Cmax)
History
Last registry update
Registered
Primary completion
Started