An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pregabalin immediate release, 300 mg; Drug: Pregabalin controlled release, 330 mg, low-fat; Drug: Pregabalin controlled release, 330 mg, medium-fat; Drug: Pregabalin controlled release, 330 mg, high-fat

Study type: Interventional

Funder types: Industry

Identifiers

NCT01257529

A0081227

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 tablet following either a low, medium, or high-fat evening meal as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following a low, medium, or high fat evening meal 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: 28 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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28 participants in 4 patient groups

Pregabalin controlled release, 330 mg, low-fat

Experimental group

Treatment:

Drug: Pregabalin controlled release, 330 mg, low-fat

Pregabalin controlled release, 330 mg, medium-fat

Experimental group

Treatment:

Drug: Pregabalin controlled release, 330 mg, medium-fat

Pregabalin controlled release, 330 mg, high-fat

Experimental group

Treatment:

Drug: Pregabalin controlled release, 330 mg, high-fat

Pregabalin immediate release, 300 mg

Other group

Description:

Reference Treatment

Treatment:

Drug: Pregabalin immediate release, 300 mg