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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 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.

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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

Healthy

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

FieldValue
Enrollment Target 24 participants
Start Date 2011-04
Est. Completion 2011-06
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 NCT01321671

The ClinicalTrials.gov registry entry for NCT01321671 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, 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 3 interventions - of which Pregabalin immediate release, 300 mg is the first listed.

NCT01321671 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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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.