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NCT01291524 · ClinicalTrials.gov registry record · Phase 1
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
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
NCT01291524 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.
The verdict
NCT01291524, 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 extent of absorption of a single dose of a pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750 calorie evening meal as compared to a single dose of the pregabalin immediate release (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet administered with various caloric sized dinners and at bedtime as compared to a single dose of the pregabalin immediate release capsule.
Interventions
- DRUG Pregabalin immediate release, 300 mg
- DRUG Pregabalin controlled release, 330 mg, 600- 750 calorie
- DRUG Pregabalin controlled release, 330 mg, 400 to 500 calorie
- DRUG Pregabalin controlled release, 330 mg, bedtime
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-02 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01291524
The ClinicalTrials.gov registry entry for NCT01291524 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Pregabalin immediate release, 300 mg is the first listed.
NCT01291524 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01291524 about?
NCT01291524 is a clinical study titled "Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 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 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750 calorie evening meal as compar...
What is the current status of trial NCT01291524?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-02. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01291524?
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, 400 to 500 calorie (DRUG), Pregabalin controlled release, 330 mg, bedtime (DRUG).
Who is sponsoring clinical trial NCT01291524?
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.
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