An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet
NCT ID: NCT01342198
Last Updated: 2021-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2011-06-30
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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1
Single Dose Pregabalin Controlled Release
Pregabalin controlled release, 330 mg
A single oral dose of 330 mg controlled release tablet
2
Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin
Pregabalin controlled release, 330 mg
A single oral dose of 330 mg controlled release tablet
erythromycin
A total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR
Interventions
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Pregabalin controlled release, 330 mg
A single oral dose of 330 mg controlled release tablet
Pregabalin controlled release, 330 mg
A single oral dose of 330 mg controlled release tablet
erythromycin
A total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR
Eligibility Criteria
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Inclusion Criteria
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
Exclusion Criteria
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Brussels, , Belgium
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081197
Identifier Type: -
Identifier Source: org_study_id
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