Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01291524
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Duration (Months): 2.9
• Patients Per Site Per Month: 8.2

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 (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750 calorie evening meal as compared to a single dose of the pregabalin immediate release (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet administered with various caloric sized dinners and at bedtime 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, 400 to 500 calorie; Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie; Drug: Pregabalin controlled release, 330 mg, bedtime; 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: 24 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 Caloric Content And Time Of Dosing On The Pharmacokinetics Of Pregabalin Controlled Release Formulation As Compared To The Immediate Release Formulation
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pregabalin controlled release, 330 mg, 400-500 calorie	Drug: Pregabalin controlled release, 330 mg, 400 to 500 calorie; A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie evening meal
Experimental: Pregabalin controlled release, 330 mg, 600- 750 calorie	Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie; A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie evening meal
Experimental: Pregabalin controlled release, 330 mg, bedtime	Drug: Pregabalin controlled release, 330 mg, bedtime; A single oral dose of 330 mg controlled release tablet administered at bedtime
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 in the evening

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	New Haven	Connecticut	United States	06511

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: NCT01291524
• Other Study ID Numbers: A0081238
• First Posted: Feb 8, 2011
• Last Update Posted: Jan 22, 2021
• Last Verified: May 1, 2011

• 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