A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 300 mg pregabalin immediate release; Drug: 330 mg pregabalin controlled release

Study type: Interventional

Funder types: Industry

Identifiers

NCT01080612

A0081239

Details and patient eligibility

About

The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.

Full description

To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.

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

330 mg pregabalin controlled release: 400 to 500 calories

Experimental group

Treatment:

Drug: 330 mg pregabalin controlled release

Drug: 330 mg pregabalin controlled release

Drug: 330 mg pregabalin controlled release

330 mg pregabalin controlled release: 600 to 750 calories

Experimental group

Treatment:

Drug: 330 mg pregabalin controlled release

Drug: 330 mg pregabalin controlled release

Drug: 330 mg pregabalin controlled release

330 mg pregabalin controlled release: 800 to 1000 calories

Experimental group

Treatment:

Drug: 330 mg pregabalin controlled release

Drug: 330 mg pregabalin controlled release

Drug: 330 mg pregabalin controlled release

300 mg pregabalin immediate release

Other group

Treatment:

Drug: 300 mg pregabalin immediate release