At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 76 enrolled
Drug / intervention
Atorvastatin +1 moredrug
Likely dose
Atorvastatin 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, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet In Healthy Subjects
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jun 10, 2009·Updated Feb 21, 2021
In Brief
A Phase 4 clinical trial evaluating Atorvastatin for Hypercholesterolemia. Completed, enrolled 76 participants across 1 site.
Detailed Summary
To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
Primary CompletionSep 2008
First PostedJun 2009
TodayJul 2026
First PostedJun 10, 2009
Enrollment StartJul 1, 2008
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.1 years ago
Interventions
Atorvastatindrug
A single 80 mg dose of marketed 80 mg atorvastatin tablets
Atorvastatingenetic
A single dose of new formulation of 80 mg atorvastatin tablets