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NCT01257529 · ClinicalTrials.gov registry record · Phase 1
An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) 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
- 28
- Enrollment target
- 1
- Study location
NCT01257529: Completed Phase 1 study of Healthy, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT01257529 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 28 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
NCT01257529, 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
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following either a low, medium, or high-fat evening meal as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following a low, medium, or high fat evening meal as compared to a single dose of the pregabalin immediate release capsule.
Conditions Studied
Interventions
- DRUG Pregabalin controlled release, 330 mg, low-fat
- DRUG Pregabalin controlled release, 330 mg, medium-fat
- DRUG Pregabalin controlled release, 330 mg, high-fat
- DRUG Pregabalin immediate release, 300 mg
Study Locations (1)
Kansas
- Pfizer Investigational Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
What the finished NCT01257529 record still lists
NCT01257529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 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 4 interventions - of which Pregabalin controlled release, 330 mg, low-fat is the first listed.
NCT01257529 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT01257529 about?
NCT01257529 is a clinical study titled "An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers". The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following either a low, medium, or high-fat evening meal as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the safety and tolerability o...
What is the current status of trial NCT01257529?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2011-03. Estimated completion is 2011-04.
What conditions does trial NCT01257529 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01257529?
The interventions under investigation include: Pregabalin controlled release, 330 mg, low-fat (DRUG), Pregabalin controlled release, 330 mg, medium-fat (DRUG), Pregabalin controlled release, 330 mg, high-fat (DRUG), Pregabalin immediate release, 300 mg (DRUG).
Who is sponsoring clinical trial NCT01257529?
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 NCT01257529 being conducted?
This trial has 1 study location across Kansas. 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 NCT01257529's enrollment target sits among peer trials
28 736th of 1090 higher than 340 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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