Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 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 immediate release, 300 mg; Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie; Drug: Pregabalin controlled release, 330 mg, fasted

Study type: Interventional

Funder types: Industry

Identifiers

NCT01321671

A0081228

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics of a single dose of a pregabalin controlled release (CR) tablet administered fasted in the evening relative to a single dose of the CR tablet administered immediately following a 600 to 750 calorie evening meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR) capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated.

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 3 patient groups

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, fasted

Experimental group

Treatment:

Drug: Pregabalin controlled release, 330 mg, fasted

Pregabalin immediate release, 300 mg

Other group

Treatment:

Drug: Pregabalin immediate release, 300 mg