NCT06225635

A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Ezerosu Tab

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Shin Poong Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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

Conditions

• Hyperlipidemias

Interventions

Type	Name	Description
DRUG	Ezerosu(monolayer tablet)	Ezetimibe 10mg, Rosuvastatin calcium 20.8mg(20mg as Rosuvastatin)
DRUG	Ezerosu(double layer tablet)	Ezetimibe 10mg, Rosuvastatin calcium 20.8mg(20mg as Rosuvastatin)

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-03-07
• Completion: 2022-03-07
• First posted: 2024-01-26
• Last updated: 2024-01-26

Locations

1 site across 1 country: South Korea