Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 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: NCT01321671
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 12

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of a single dose of a pregabalin controlled release (CR) tablet administered fasted in the evening relative to a single dose of the CR tablet administered immediately following a 600 to 750 calorie evening meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR) capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Pregabalin controlled release, 330 mg, 600- 750 calorie; Drug: Pregabalin controlled release, 330 mg, fasted; 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: The Pharmacokinetics Of Pregabalin Controlled Release Formulation In Fed State Compared To The Controlled Release And Immediate Release Formulations In The Fasted State
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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, fasted	Drug: Pregabalin controlled release, 330 mg, fasted; A single oral dose of 330 mg controlled release tablet administered fasted in the evening
Other: Pregabalin immediate release, 300 mg	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) and peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) fed and CR fasted [3 days]

2. Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatment [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: NCT01321671
• Other Study ID Numbers: A0081228
• First Posted: Mar 23, 2011
• Last Update Posted: Jan 22, 2021
• Last Verified: Jun 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