A Phase 1 interventional study of Pregabalin controlled release, 330 mg, low-fat and Pregabalin controlled release, 330 mg, medium-fat 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 2021-01-22.
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 following either a low, medium, or high-fat evening meal as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following a low, medium, or high fat evening meal as compared to a single dose of the pregabalin immediate release capsule.
Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule
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: Pregabalin controlled release, 330 mg, low-fat
Drug: Pregabalin controlled release, 330 mg, medium-fat
Drug: Pregabalin controlled release, 330 mg, high-fat
Reference Treatment
Drug: Pregabalin immediate release, 300 mg
A single oral dose of 330 mg controlled release tablet administered following a low-fat evening meal
A single oral dose of 330 mg controlled release tablet administered following a medium-fat evening meal
A single oral dose of 330 mg controlled release tablet administered following a high-fat evening meal
A single oral dose of 300 mg immediate release capsule administered following a medium-fat evening meal
Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments
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 Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.