NCT01342198

Brief Summary

The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin and 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 22, 2021

Status Verified

July 1, 2011

Enrollment Period

1 month

First QC Date

April 21, 2011

Last Update Submit

January 21, 2021

Conditions

Healthy

Keywords

pregabalinpharmacokineticsbioavailabilitybioequivalence

Outcome Measures

Primary Outcomes (2)

  • Area under the curve from 0 to infinity (AUCinf)

    3 days

  • Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin

    3 days

Secondary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    3 days

Study Arms (2)

1

EXPERIMENTAL

Single Dose Pregabalin Controlled Release

Drug: Pregabalin controlled release, 330 mg

2

EXPERIMENTAL

Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin

Drug: Pregabalin controlled release, 330 mgDrug: erythromycin

Interventions

Pregabalin controlled release, 330 mgDRUG

A single oral dose of 330 mg controlled release tablet

1
erythromycinDRUG

A total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or females
  • Between the ages of 18 and 55 years, inclusive
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

You may not qualify if:

  • Illicit drug use
  • Pregnant or nursing females
  • Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

MeSH Terms

Interventions

Erythromycin

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2011

First Posted

April 27, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 22, 2021

Record last verified: 2011-07

Locations

BE(1)