A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)

Phase 1

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Ezetimibe/atorvastatin 10mg/80mg FDC; Drug: Ezetimibe/atorvastatin 10mg/10mg FDC; Drug: Ezetimibe; Drug: Atorvastatin 10mg; Drug: Atorvastatin 80mg

• Registration Number: NCT01236430
• Lead Sponsor: Organon and Co

Brief Summary

The intent of this study is to demonstrate that single doses of the Final Market Image (FMI) ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are bioequivalent to the same doses of ezetimibe (ZETIA®) and atorvastatin (LIPITOR®) that are coadministered as individual tablets in healthy adults.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-07
• Study Start: 2011-02
• Primary Completion: 2011-11
• Study Completion: 2012-02
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ezetimibe 10mg and Atorvastatin 10mg	Atorvastatin 10mg	Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered
10mg Ezetimibe/80mg Atorvastatin	Ezetimibe/atorvastatin 10mg/80mg FDC	Ezetimibe/atorvastatin 10mg/80mg combination tablet
10mg Ezetimibe/10mg Atorvastatin	Ezetimibe/atorvastatin 10mg/10mg FDC	10mg Ezetimibe/10mg atorvastatin combination tablet
Ezetimibe 10mg and Atorvastatin 80mg	Ezetimibe	Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered
Ezetimibe 10mg and Atorvastatin 80mg	Atorvastatin 80mg	Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered
Ezetimibe 10mg and Atorvastatin 10mg	Ezetimibe	Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of atorvastatin	Hour 0 to Hour 48
Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ)	Hour 0 to Hour 96
Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatin	Hour 0 to Hour 48
Area under the concentration time-curves from time zero to the time of last measured concentration (AUC0-last) of unconjugated ezetimibe (EZ)	Hour 0 to Hour 96