At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 12 enrolled
Drug / intervention
Atorvastatin suspension +1 moredrug
Likely dose
Atorvastatin suspension 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Single Dose, Randomized 2-Way Crossover Study To Estimate The Relative Bioavailability Of Atorvastatin Commercial Tablet, And An Extemporaneous Preparation (EP) Suspension Formulation, In Healthy Subjects
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Feb 16, 2009·Updated Mar 10, 2021
In Brief
A Phase 4 clinical trial evaluating Atorvastatin suspension and Lipitor for Hypercholesterolemia. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study is to estimate the relative bioavailability of the commercial tablet with one prototype extemporaneous preparation suspension formulation, to assist with internal decision making on formulation development.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
Primary CompletionMar 2008
First PostedFeb 2009
TodayJul 2026
First PostedFeb 16, 2009
Enrollment StartFeb 1, 2008
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Atorvastatin suspensiondrug
A single dose of 80 mg Atorvastatin suspension
Lipitordrug
A single dose of 80 mg Lipitor tablet