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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 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.

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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

Healthy

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

FieldValue
Enrollment Target 28 participants
Start Date 2011-03
Est. Completion 2011-04
Phase Phase 1

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris

158 total trials

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What the Registry Record Tells You About NCT01257529

The ClinicalTrials.gov registry entry for NCT01257529 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, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). 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 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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.