An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers

NCT01270815 | Completed Phase 1

• 1 other identifier: A0081188
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following various sized lunches as compared to a single dose of the pregabalin immediate release capsule.

Conditions

Healthy

Keywords

pregabalin; pharmacokinetics; bioavailability; bioequivalence

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  3 days

Study Arms (4)

Pregabalin controlled release, 330 mg, 400 to 500 calories

EXPERIMENTAL

Drug: Pregabalin controlled release, 330 mg, 400 to 500 calories

Pregabalin controlled release, 330 mg, 600 to 750 calories

EXPERIMENTAL

Drug: Pregabalin controlled release, 330 mg, 600 to 750 calories

Pregabalin controlled release, 330 mg, 800 to 1000 calories

EXPERIMENTAL

Drug: Pregabalin controlled release, 330 mg, 800 to 1000 calories

Pregabalin immediate release, 300 mg

OTHER

Reference

Drug: Pregabalin immediate release, 300 mg

Interventions

Pregabalin controlled release, 330 mg, 400 to 500 calories DRUG

A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch

Pregabalin controlled release, 330 mg, 400 to 500 calories

Pregabalin controlled release, 330 mg, 600 to 750 calories DRUG

A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch

Pregabalin controlled release, 330 mg, 600 to 750 calories

Pregabalin controlled release, 330 mg, 800 to 1000 calories DRUG

A single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch

Pregabalin controlled release, 330 mg, 800 to 1000 calories

Pregabalin immediate release, 300 mg DRUG

A single oral dose of 300 mg immediate release capsule administered fasted

Pregabalin immediate release, 300 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Illicit drug use
• Pregnant or nursing females
• Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Sponsors & Collaborators

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

Study Sites (1)

Pfizer Investigational Site

Overland Park, Kansas, 66211, United States

Location

Related Publications (1)

• Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4.

  PMID: 25078976 DERIVED

Related Links

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

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 22, 2021

Record last verified: 2011-05

Locations

US (1)