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Completed

NCT Number: NCT01009541

An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin controlled release, 82.5 mg

Drug

82.5 mg controlled release tablet administered once daily for three days.

Pregabalin controlled release, 165 mg

Drug

165 mg controlled release tablet administered once daily for three days.

Pregabalin controlled release, 330 mg

Drug

330 mg controlled release tablet administered once daily for three days.

Pregabalin immediate release, 150 mg

Drug

150 mg immediate release capsules administered every 12 hours for three days

Primary outcomes

  1. Area under the curve at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ

    Time frame: 5 days

  2. Minimum plasma concentration at steady-state within a dosing interval (Cmin)

    Time frame: 5 days

  3. Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax)

    Time frame: 5 days

  4. The average plasma concentration at steady-state (Cav), half-life

    Time frame: 5 days

  5. Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS)

    Time frame: 5 days

Secondary outcomes

  1. Safety endpoints include evaluation of adverse events.

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

An Open-Label, Multiple-Dose, Randomized, Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Three Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal As Compared To The Immediate Release Formulation

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 6, 2009
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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