A Phase 1 interventional study of Pregabalin controlled release, 330 mg and Pregabalin controlled release, 330 mg in Healthy, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 1, Interventional, and Other
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.
Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet with and without erythromycin
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single Dose Pregabalin Controlled Release
Drug: Pregabalin controlled release, 330 mg
Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin
Drug: Pregabalin controlled release, 330 mg · Drug: erythromycin
A single oral dose of 330 mg controlled release tablet
A single oral dose of 330 mg controlled release tablet
A total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR
Area under the curve from 0 to infinity (AUCinf)
Time frame: 3 days
Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin
Time frame: 3 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 days
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.