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

NCT01236430 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-02-16

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Michael Seiberling, MD · Covance Clinical Research Unit AG, Lettenweg 118, CH-4123 Allschwil (Basel), Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-11-30
Completion
2012-02-29

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01236430 on ClinicalTrials.gov