An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers

NCT01257516 | Completed Phase 1

• 1 other identifier: A0081216
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule.

Conditions

Healthy

Keywords

pregabalin; pharmacokinetics; bioavailability; bioequivalence

Outcome Measures

Primary Outcomes (1)

• Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 330 mg CR (two tablets administered concurrently for a total 660 mg dose) and 300 mg IR capsule given 2times daily (total daily dose 600 mg)

  5 days

Secondary Outcomes (1)

• Safety endpoints include evaluation of adverse events

  5 days

Study Arms (2)

Pregabalin immediate release, 300 mg

OTHER

Reference Treatment

Drug: Pregabalin immediate release, 300 mg

Pregabalin controlled release, 330 mg

EXPERIMENTAL

Drug: Pregabalin controlled release, 330 mg

Interventions

Pregabalin immediate release, 300 mg DRUG

300 mg immediate release capsule administered twice daily for four days

Pregabalin immediate release, 300 mg

Pregabalin controlled release, 330 mg DRUG

Two tablets of 330 mg (total dose of 660 mg) given concurrently once daily for four days

Pregabalin controlled release, 330 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

Brussels, B-1070, Belgium

Location

Related Publications (1)

• Chew ML, Alvey CW, Plotka A, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):627-37. doi: 10.1007/s40261-014-0221-2.

  PMID: 25078977 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: December 8, 2010
• First Posted: December 9, 2010
• Study Start: February 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 22, 2021

Record last verified: 2011-03

Locations

BE (1)