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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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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