Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pregabalin controlled release, 330 mg, 400 to 500 calorie; Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie; Drug: Pregabalin controlled release, 330 mg, bedtime; Drug: Pregabalin immediate release, 300 mg

• Registration Number: NCT01291524
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750 calorie evening meal as compared to a single dose of the pregabalin immediate release (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet administered with various caloric sized dinners and at bedtime as compared to a single dose of the pregabalin immediate release capsule.

Detailed Description

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

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy male or females
• Between the ages of 18 and 55 years, inclusive
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria

• Illicit drug use
• Pregnant or nursing females
• Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pregabalin controlled release, 330 mg, 400-500 calorie	Pregabalin controlled release, 330 mg, 400 to 500 calorie	-
Pregabalin controlled release, 330 mg, 600- 750 calorie	Pregabalin controlled release, 330 mg, 600- 750 calorie	-
Pregabalin controlled release, 330 mg, bedtime	Pregabalin controlled release, 330 mg, bedtime	-
Pregabalin immediate release, 300 mg	Pregabalin immediate release, 300 mg	Reference Treatment

Primary Outcome Measures

Name	Time	Method
Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments	3 days

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	3 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States