A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01080612
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Duration (Months): 2
• Patients Per Site Per Month: 12

Study Details

Study Description

Brief Summary

The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: 330 mg pregabalin controlled release; Drug: 330 mg pregabalin controlled release; Drug: 330 mg pregabalin controlled release; Drug: 300 mg pregabalin immediate release	Phase 1

Detailed Description

To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.

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 Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered Following Various Caloric Intakes As Compared To The Immediate Release Formulation
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 330 mg pregabalin controlled release: 400 to 500 calories	Drug: 330 mg pregabalin controlled release; A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal
Experimental: 330 mg pregabalin controlled release: 600 to 750 calories	Drug: 330 mg pregabalin controlled release; A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal
Experimental: 330 mg pregabalin controlled release: 800 to 1000 calories	Drug: 330 mg pregabalin controlled release; A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal
Other: 300 mg pregabalin immediate release	Drug: 300 mg pregabalin immediate release; A single dose of 300 mg immediate release capsule will be administered in the fasted state

Outcome Measures

Primary Outcome Measures

1. Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf) [3 days]

Secondary Outcome Measures

1. Adverse events, vital signs, and clinical safety laboratories. [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: NCT01080612
• Other Study ID Numbers: A0081239
• First Posted: Mar 4, 2010
• Last Update Posted: Jan 29, 2021
• Last Verified: Jul 1, 2010

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

Study Results

No Results Posted as of Jan 29, 2021