NCT02725112

Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers

A Phase 1, Randomized, Open-label, Single-dose, 6-period Study To Investigate The Effect Of In Vitro Dissolution Rate On The In Vivo Bioavailability Of Extended Release Formulations Of Pregabalin In Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pregabalin ER	A: Pregabalin ER tablet formulation, Target release rate, 1 x 330 mg, Oral.
DRUG	Pregabalin ER	B: Pregabalin ER tablet formulation, Slow release rate, 1 x 330 mg, Oral.
DRUG	Pregabalin ER	C: Pregabalin ER tablet formulation, Fast release rate, 1 x 330 mg, Oral.
DRUG	Pregabalin ER	D: Pregabalin IR capsule formulation, 1 x 300 mg, Oral.
DRUG	Pregabalin ER	E: Pregabalin ER tablet formulation, Target release rate, 1 x 82.5 mg, Oral.
DRUG	Pregabalin ER	F: Pregabalin ER tablet formulation, Aberrant fast release rate, 1 x 330 mg, Oral.

Timeline

• Start date: 2016-02-12
• Primary completion: 2016-05-22
• Completion: 2016-06-17
• First posted: 2016-03-31
• Last updated: 2021-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study