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NCT01270815 · 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 Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) 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
- 28
- Enrollment target
NCT01270815 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 28 participants.
The verdict
NCT01270815, 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
- 28 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 tablet following a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following various sized lunches 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, 400 to 500 calories
- DRUG Pregabalin controlled release, 330 mg, 600 to 750 calories
- DRUG Pregabalin controlled release, 330 mg, 800 to 1000 calories
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01270815
The ClinicalTrials.gov registry entry for NCT01270815 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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.
NCT01270815 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01270815 about?
NCT01270815 is a clinical study titled "An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches 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 a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2) evaluate the safety and t...
What is the current status of trial NCT01270815?
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 interventions are being tested in trial NCT01270815?
The interventions under investigation include: Pregabalin immediate release, 300 mg (DRUG), Pregabalin controlled release, 330 mg, 400 to 500 calories (DRUG), Pregabalin controlled release, 330 mg, 600 to 750 calories (DRUG), Pregabalin controlled release, 330 mg, 800 to 1000 calories (DRUG).
Who is sponsoring clinical trial NCT01270815?
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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