Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475872
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-06-17
Brief Title:
Study to Evaluate the Bioequivalence of Crecheck Tablet 25 mg Rosuvastatin Calcium and Crestor Tablet 5 mg Rosuvastatin Calcium in Healthy Adult Subjects
Sponsor:
Hanlim Pharm Co Ltd
Organization:
Hanlim Pharm Co Ltd
Study Overview
Official Title:
Open Randomized 2-Group 2-Period Fasting Single-Dose Crossover Study to Evaluate the Bioequivalence of Crecheck Tablet 25 mg Rosuvastatin Calcium of Hanlim Pharm Co Ltd and Crestor Tablet 5 mg Rosuvastatin Calcium of AstraZeneca Korea Co Ltd in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25 mg Rosuvastatin Calcium of Hanlim Pharm Co Ltd and Crestor Tablet 5 mg Rosuvastatin Calcium of AstraZeneca Korea Co Ltd in healthy adult subjects
Detailed Description:
This study is to compare and evaluate the safety and pharmacokinetic characteristics of Hanlim Pharm Co Ltds Crecheck Tablet 25 mg Rosuvastatin Calcium as the test drug and AstraZeneca Korea Co Ltds Crestor Tablet 5 mg Rosuvastatin Calcium as the reference drug in healthy adults
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None