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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Pregabalin controlled release, 82.5 mg; Drug: Pregabalin controlled release, 165 mg; Drug: Pregabalin controlled release, 330 mg; Drug: Pregabalin immediate release, 150 mg

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregabalin controlled release, 82.5 mg	Drug: Pregabalin controlled release, 82.5 mg; 82.5 mg controlled release tablet administered once daily for three days.
Experimental: Pregabalin controlled release, 165 mg	Drug: Pregabalin controlled release, 165 mg; 165 mg controlled release tablet administered once daily for three days.
Experimental: Pregabalin controlled release, 330 mg	Drug: Pregabalin controlled release, 330 mg; 330 mg controlled release tablet administered once daily for three days.
Other: Pregabalin immediate release, 150 mg; Reference Treatment	Drug: Pregabalin immediate release, 150 mg; 150 mg immediate release capsules administered every 12 hours for three days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ	5 days
Minimum plasma concentration at steady-state within a dosing interval (Cmin)	5 days
Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax)	5 days
The average plasma concentration at steady-state (Cav), half-life	5 days
Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS)	5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety endpoints include evaluation of adverse events.	5 days

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: November 5, 2009
• First Submitted That Met QC Criteria: November 5, 2009
• First Posted (Estimate): November 6, 2009

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: pregabalin pharmacokinetics bioavailability bioequivalence
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081225