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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009541
• Other study ID #: A0081225
• Status: Completed
• Phase: Phase 1
• Start date: November 2009
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Pregabalin controlled release, 82.5 mg
82.5 mg controlled release tablet administered once daily for three days.
• Pregabalin controlled release, 165 mg
165 mg controlled release tablet administered once daily for three days.
• Pregabalin controlled release, 330 mg
330 mg controlled release tablet administered once daily for three days.
• Pregabalin immediate release, 150 mg
150 mg immediate release capsules administered every 12 hours for three days

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

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

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve at steady-state for a dosing interval (AUCt), Dose-adjusted AUCt		5 days
Primary	Minimum plasma concentration at steady-state within a dosing interval (Cmin)		5 days
Primary	Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax)		5 days
Primary	The average plasma concentration at steady-state (Cav), half-life		5 days
Primary	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	Safety endpoints include evaluation of adverse events.		5 days

External Links

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