Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers
Status:
Completed
Trial end date:
2016-06-17
Target enrollment:
Participant gender:
Summary
This study is a Phase 1, randomized, open label, single dose, 6 treatment, 6 period, 6
sequence study in healthy adult volunteers. A total of 24 (4 in each treatment sequence)
healthy male and female subjects who, at the time of screening, are between the ages of 18
and 55 years, inclusive will be enrolled. Subjects who discontinue from the study may be
replaced at the Sponsor's discretion. Screening activities will be completed within
approximately 28 days prior to Day 1 of Period 1. Subjects will be randomized to 1 of the 6
treatment sequences as described in Table 1 below. Each treatment sequence will consist of 6
periods with subjects receiving single doses of pregabalin ER 330 mg target release rate
tablet, pregabalin ER 330 mg slow release rate tablet, pregabalin ER 330 mg fast release rate
tablet, pregabalin IR 300 mg capsule, pregabalin ER 82.5 mg target release rate tablet, and
pregabalin ER 330 mg aberrant fast release rate tablet formulations. All study treatments
will be administered following a 600- 750 calorie, 30% fat evening meal.
Phase:
Phase 1
Details
Lead Sponsor:
Pfizer Pfizer's Upjohn has merged with Mylan to form Viatris Inc.