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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01009541

Enrollment

Registered

2009-11-06

Start date

2009-11-30

Completion date

2009-12-31

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

pregabalin pharmacokinetics bioavailability bioequivalence

Brief summary

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.

Interventions

DRUGPregabalin controlled release, 82.5 mg

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

DRUGPregabalin controlled release, 165 mg

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

DRUGPregabalin controlled release, 330 mg

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

DRUGPregabalin immediate release, 150 mg

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026