An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule

Phase 1CompletedNCT01202435

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.18 enrolled

Overview

The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule.

Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 82.5 mg CR and 25 mg IR capsule given 3 times daily (total daily dose 75 mg)

Time frame: 5 days

Secondary Outcomes

Safety endpoints include evaluation of adverse events