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Completed

NCT Number: NCT00653276

MD Ezetimibe Cyclosporine Interaction (0653-057)

Study to determine the effect of multiple oral doses of ezetimibe on the pharmacokinetics of a single oral dose cyclosporine in young healthy males and females.

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Key information

Conditions

Cholesterol

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is male or female between 18 to 45 years of age
  • Subject is judged to be in good health on the basis of history, physical examination, and routine laboratory data

Exclusion criteria

  • Premenopausal women who are currently pregnant or who are currently nursing
  • Subjects with drug or substance abuse, poor mental function, history of major gastrointestinal abnormalities (stomach issues), or high cholesterol
  • Subject that has donated blood or has participated in another clinical trial within the last four weeks

Treatment and study plan

ezetimibe

Drug

ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.

Other names: MK0653, Zetia®

Comparator: cyclosporine

Drug

single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.

Primary outcomes

  1. To evaluate the safety and tolerability of cyclosporine coadministered with ezetimibe vs. cyclosporine administered alone.

    Time frame: Blood sampling will be conducted for 48 hours starting with the first cyclosporine dosing.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Collaborators

  • Schering-Plough

Registry information

Official study title

An Open-Label, 2-Period, Crossover Study to Determine the Effect of Multiple Oral Doses of Ezetimibe 20 mg on the Pharmacokinetics of a Single Oral Dose of Cyclosporine in Young, Healthy, Normal, Male and Female Subjects

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Apr 4, 2008
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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