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An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01342198
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
30
Duration (Days)
18.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pregabalin controlled release, 330 mg
  • Drug: Pregabalin controlled release, 330 mg
  • Drug: erythromycin
 Phase 1

Detailed Description

Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet with and without erythromycin

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Phase 1, Open-Label, Randomized, Cross-Over Study to Evaluate the Effects of Multiple Doses of Erythromycin on the Pharmacokinetics of a Single Dose of Pregabalin Controlled Release in Healthy Subjects
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Single Dose Pregabalin Controlled Release

Drug: Pregabalin controlled release, 330 mg
A single oral dose of 330 mg controlled release tablet
Experimental: 2

Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin

Drug: Pregabalin controlled release, 330 mg
A single oral dose of 330 mg controlled release tablet

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

Outcome Measures

Primary Outcome Measures

  1. Area under the curve from 0 to infinity (AUCinf) [3 days]

  2. Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin [3 days]

Secondary Outcome Measures

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Illicit drug use

  • Pregnant or nursing females

  • Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Bruxelles Belgium B-1070

Sponsors and Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT01342198
Other Study ID Numbers:
  • A0081197
First Posted:
Apr 27, 2011
Last Update Posted:
Jan 22, 2021
Last Verified:
Jul 1, 2011
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
pregabalin
pharmacokinetics
bioavailability
bioequivalence
Additional relevant MeSH terms:
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Pregabalin

Study Results

No Results Posted as of Jan 22, 2021