NCT01236430

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

A Study to Evaluate the Definitive Bioequivalence of SCH 900068 With Marketed Products (Protocol No. P07551)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Ezetimibe	Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).
DRUG	Ezetimibe/atorvastatin 10mg/10mg FDC	Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours).
DRUG	Atorvastatin 10mg	Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).
DRUG	Atorvastatin 80mg	Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).
DRUG	Ezetimibe/atorvastatin 10mg/80mg FDC	Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours).

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-11-01
• Completion: 2012-02-01
• First posted: 2010-11-08
• Last updated: 2022-02-16