An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Pregabalin controlled release, 330 mg (Drug); Pregabalin controlled release, 330 mg (Drug); erythromycin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Area under the curve from 0 to infinity (AUCinf)Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin
Secondary outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Detailed description:
Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a
pregabalin CR tablet with and without erythromycin
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pfizer Investigational Site, Bruxelles B-1070, Belgium
Additional Information
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Starting date: June 2011
Last updated: July 27, 2011
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