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

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie; Drug: Pregabalin controlled release, 330 mg, bedtime; Drug: Pregabalin controlled release, 330 mg, 400 to 500 calorie; Drug: Pregabalin immediate release, 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01291524

A0081238

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Pregabalin controlled release, 330 mg, 400-500 calorie

Experimental group

Treatment:

Drug: Pregabalin controlled release, 330 mg, 400 to 500 calorie

Pregabalin controlled release, 330 mg, 600- 750 calorie

Experimental group

Treatment:

Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie

Pregabalin controlled release, 330 mg, bedtime

Experimental group

Treatment:

Drug: Pregabalin controlled release, 330 mg, bedtime

Pregabalin immediate release, 300 mg

Other group

Description:

Reference Treatment

Treatment:

Drug: Pregabalin immediate release, 300 mg