A Phase 1 interventional study of 330 mg pregabalin controlled release and 330 mg pregabalin controlled release in Healthy, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-29.
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 effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.
To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.
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:
Drug: 330 mg pregabalin controlled release
Drug: 330 mg pregabalin controlled release
Drug: 330 mg pregabalin controlled release
Drug: 300 mg pregabalin immediate release
A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal
A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal
A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal
A single dose of 300 mg immediate release capsule will be administered in the fasted state
Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf)
Time frame: 3 days
Adverse events, vital signs, and clinical safety laboratories.
Time frame: 3 days
This study is completed, as verified in Jul 2010. 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.