A Phase 1 interventional study of Pregabalin controlled release, 82.5 mg and Pregabalin immediate release, 25 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 multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule.
Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release 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, 82.5 mg
Reference Treatment
Drug: Pregabalin immediate release, 25 mg
82.5 mg controlled release tablet administered once daily for four days.
25 mg immediate release capsules administered three times daily for four days
Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 82.5 mg CR and 25 mg IR capsule given 3 times daily (total daily dose 75 mg)
Time frame: 5 days
Safety endpoints include evaluation of adverse events
Time frame: 5 days
This study is completed, as verified in Dec 2010. 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.