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

Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Pregabalin controlled release, 82.5 mg (Drug); Pregabalin immediate release, 25 mg (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Summary

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

Clinical Details

Official title: An Open-Label, Multiple-Dose, Randomized, 2-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of The 82.5 Mg Pregabalin Controlled Release Formulation Administered Following An Evening Meal Relative To The 25 Mg Of The Immediate Release Formulation Administered Three Times Daily

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 82.5 mg CR and 25 mg IR capsule given 3 times daily (total daily dose 75 mg)

Secondary outcome: Safety endpoints include evaluation of adverse events

Detailed description: Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Bruxelles B-1070, Belgium
Additional Information

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

Starting date: October 2010
Last updated: September 14, 2010

Page last updated: October 04, 2010

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