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NCT01321671 · ClinicalTrials.gov registry record · Phase 1
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
A Phase 1 study of Healthy, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01321671: Completed Phase 1 study of Healthy, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT01321671 is a Phase 1 study of Healthy that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 24 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01321671, a Phase 1 study of Healthy, 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
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the pharmacokinetics of a single dose of a pregabalin controlled release (CR) tablet administered fasted in the evening relative to a single dose of the CR tablet administered immediately following a 600 to 750 calorie evening meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR) capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated.
Conditions Studied
Interventions
- DRUG Pregabalin immediate release, 300 mg
- DRUG Pregabalin controlled release, 330 mg, 600- 750 calorie
- DRUG Pregabalin controlled release, 330 mg, fasted
Study Locations (1)
Connecticut
- Pfizer Investigational Site - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-04 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
What the finished NCT01321671 record still lists
NCT01321671 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 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Pregabalin immediate release, 300 mg is the first listed.
NCT01321671 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT01321671 about?
NCT01321671 is a clinical study titled "Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers". The purpose of this study is to evaluate the pharmacokinetics of a single dose of a pregabalin controlled release (CR) tablet administered fasted in the evening relative to a single dose of the CR tablet administered immediately following a 600 to 750 calorie evening meal. The single dose pharmacoki...
What is the current status of trial NCT01321671?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-04. Estimated completion is 2011-06.
What conditions does trial NCT01321671 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01321671?
The interventions under investigation include: Pregabalin immediate release, 300 mg (DRUG), Pregabalin controlled release, 330 mg, 600- 750 calorie (DRUG), Pregabalin controlled release, 330 mg, fasted (DRUG).
Who is sponsoring clinical trial NCT01321671?
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.
Where is trial NCT01321671 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01321671's enrollment target sits among peer trials
24 791st of 1090 higher than 254 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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