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NCT01080612 · ClinicalTrials.gov registry record · Phase 1
A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation
A Phase 1 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01080612: Completed Phase 1 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT01080612 is a Phase 1 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01080612, a Phase 1 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.
Interventions
- DRUG 330 mg pregabalin controlled release
- DRUG 300 mg pregabalin immediate release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-04 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT01080612 record still lists
NCT01080612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which 330 mg pregabalin controlled release is the first listed.
NCT01080612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01080612 about?
NCT01080612 is a clinical study titled "A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation". The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single ...
What is the current status of trial NCT01080612?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-04. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01080612?
The interventions under investigation include: 330 mg pregabalin controlled release (DRUG), 300 mg pregabalin immediate release (DRUG).
Who is sponsoring clinical trial NCT01080612?
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 NCT01080612's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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