NCT02725112

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

Completed Phase 1 Last updated 20 January 2021

What this trial tests

Phase 1 trial testing Pregabalin ER in Healthy in 25 participants. Completed in 17 June 2016.

Timeline

12 February 2016

Primary endpoint
22 May 2016

17 June 2016

Quick facts

Lead sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	25
Start date	12 February 2016
Primary completion	22 May 2016
Estimated completion	17 June 2016
Sites	1 location across United States

Drugs / interventions tested

• Pregabalin ER
• Pregabalin ER
• Pregabalin ER
• Pregabalin ER
• Pregabalin ER
• Pregabalin ER

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.