An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01257529
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 4
• Duration (Months): 1
• Patients Per Site Per Month: 27.5

Study Details

Study Description

Brief Summary

The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following either a low, medium, or high-fat evening meal as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following a low, medium, or high fat evening meal as compared to a single dose of the pregabalin immediate release capsule.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Pregabalin controlled release, 330 mg, low-fat; Drug: Pregabalin controlled release, 330 mg, medium-fat; Drug: Pregabalin controlled release, 330 mg, high-fat; Drug: Pregabalin immediate release, 300 mg	Phase 1

Detailed Description

Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Evaluate The Effects Of A Low, Medium And High Fat Evening Meal On The Pharmacokinetics Of Pregabalin Controlled Release Formulation As Compared To The Immediate Release Formulation
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pregabalin controlled release, 330 mg, low-fat	Drug: Pregabalin controlled release, 330 mg, low-fat; A single oral dose of 330 mg controlled release tablet administered following a low-fat evening meal
Experimental: Pregabalin controlled release, 330 mg, medium-fat	Drug: Pregabalin controlled release, 330 mg, medium-fat; A single oral dose of 330 mg controlled release tablet administered following a medium-fat evening meal
Experimental: Pregabalin controlled release, 330 mg, high-fat	Drug: Pregabalin controlled release, 330 mg, high-fat; A single oral dose of 330 mg controlled release tablet administered following a high-fat evening meal
Other: Pregabalin immediate release, 300 mg Reference Treatment	Drug: Pregabalin immediate release, 300 mg; A single oral dose of 300 mg immediate release capsule administered following a medium-fat evening meal

Outcome Measures

Primary Outcome Measures

1. Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments [3 days]

Secondary Outcome Measures

1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Overland Park	Kansas	United States	66211

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT01257529
• Other Study ID Numbers: A0081227
• First Posted: Dec 9, 2010
• Last Update Posted: Jan 22, 2021
• Last Verified: Sep 1, 2018

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: pregabalin; pharmacokinetics; bioavailability; bioequivalence
• Additional relevant MeSH terms: Pregabalin

Study Results

No Results Posted as of Jan 22, 2021