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 In Healthy Volunteers

Healthy Clinical Trial

Official title:

An Open-Label, Multiple-Dose, Randomized, 3-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of The 82.5 Mg And 165 Mg Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal And 75 Mg Of The Immediate Release Formulation Administered Twice Daily

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220219
• Other study ID #: A0081226
• Status: Completed
• Phase: Phase 1
• Start date: November 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• 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
Two tablets of 82.5 mg controlled release (administered concurrently) once daily for four days.
• Pregabalin controlled release, 165 mg
165 mg controlled release tablet administered once daily for four days.
• Pregabalin immediate release, 75mg
75 mg immediate release capsule administered every 12 hours for four 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 over a 24 hour period (AUC24)for assessment of equivalence between 165 mg CR and 75 mg IR (total daily dose 150 mg)		5 days
Primary	AUC24 and maximum plasma concentration over a 24 hour period (Cmax) at steady-state for assessment of equivalence between the 82.5 mg CR (two tablets administered concurrently) and 165 mg CR		5 days
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		5 days

External Links

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