Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT06225635
Status:
COMPLETED
Last Update Posted:
2024-01-26
First Post:
2021-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab
Sponsor:
Shin Poong Pharmaceutical Co. Ltd.
Organization:
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab. 10/20 mg(Single-layer Tablet) Compared to Ezerosu Tab. 10/20 mg(Double-layer Tablet) in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2022-03
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:
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab
Detailed Description:
Evaluate the Safety
1. Adverse Events
2. Concomitant Medications
3. Vital Signs
4. Laboratory Test
Pharmacokinetics
1. 1st Evaluation Variable: 1st Cmax, AUCt of Total Ezetimibe, Rosuvastatin
2. 2nd Evaluation Variable: AUC∞, Tmax, t1/2 of Total Ezetimibe, Rosuvastatin and Cmax, AUCt, AUC∞, Tmax, t1/2 of Free Ezetimibe
1. Adverse Events
2. Concomitant Medications
3. Vital Signs
4. Laboratory Test
Pharmacokinetics
1. 1st Evaluation Variable: 1st Cmax, AUCt of Total Ezetimibe, Rosuvastatin
2. 2nd Evaluation Variable: AUC∞, Tmax, t1/2 of Total Ezetimibe, Rosuvastatin and Cmax, AUCt, AUC∞, Tmax, t1/2 of Free Ezetimibe
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?: