Trials / Completed
CompletedNCT00844376
Bioavailability Study for New Atorvastatin Formulation
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Estimation of Relative Bioavailability
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atorvastatin suspension | A single dose of 80 mg Atorvastatin suspension |
| DRUG | Lipitor | A single dose of 80 mg Lipitor tablet |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2009-02-16
- Last updated
- 2021-03-10
- Results posted
- 2009-10-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00844376. Inclusion in this directory is not an endorsement.