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

An Open-Label, Multiple-Dose, Randomized, 3-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of The 165 Mg And 330 Mg Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal And 150 Mg Of The Immediate Release Formulation Administered Twice Daily

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01202422

Enrollment

Registered

2010-09-15

Start date

2010-10-31

Completion date

2010-11-30

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 two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two 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 two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.

Detailed description

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

Interventions

DRUGPregabalin controlled release, 165 mg

Two tablets of 165 mg controlled release (administered concurrently) once daily for four days.

DRUGPregabalin controlled release, 330 mg

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

DRUGPregabalin immediate release, 150 mg

150 mg immediate release capsules administered every 12 hours for four 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 over a 24 hour period (AUC24)for assessment of equivalence between 330 mg CR and 150 mg IR (total daily dose 300 mg)	5 days
AUC24 and maximum plasma concentration over a 24 hour period (Cmax) at steady-state for assessment of equivalence between the 165 mg CR (two tablets administered concurrently) and 330 mg CR	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