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NCT00844376 · ClinicalTrials.gov registry record · Phase 4
Bioavailability Study for New Atorvastatin Formulation
A Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT00844376: Completed Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00844376 is a Phase 4 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00844376, a Phase 4 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
Geometric means of AUC48 = area under the plasma concentration-time profile from time zero (0) to 48 hours postdose of atorvastatin (test versus \[vs\] reference); measured in nanograms times hour per milliliter (ng.hr/mL).
Interventions
- DRUG Lipitor
- DRUG Atorvastatin suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-02 |
| Est. Completion | 2008-03 |
| Phase | Phase 4 |
What the finished NCT00844376 record still lists
NCT00844376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Lipitor is the first listed.
NCT00844376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00844376 about?
NCT00844376 is a clinical study titled "Bioavailability Study for New Atorvastatin Formulation". 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.
What is the current status of trial NCT00844376?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2008-02. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00844376?
The interventions under investigation include: Lipitor (DRUG), Atorvastatin suspension (DRUG).
Who is sponsoring clinical trial NCT00844376?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00844376's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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