An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule

NCT01202422 | Completed Phase 1

• 1 other identifier: A0081198
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

pregabalin; pharmacokinetics; bioavailability; bioequivalence

Outcome Measures

Primary Outcomes (2)

• Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 330 mg CR and 150 mg IR (total daily dose 300 mg)

  5 days

• AUC24 and maximum plasma concentration over a 24 hour period (Cmax) at steady-state for assessment of equivalence between the 165 mg CR (two tablets administered concurrently) and 330 mg CR

  5 days

Secondary Outcomes (1)

• Safety endpoints include evaluation of adverse events.

  5 days

Study Arms (3)

Pregabalin controlled release, 165 mg

EXPERIMENTAL

Drug: Pregabalin controlled release, 165 mg

Pregabalin controlled release, 330 mg

EXPERIMENTAL

Drug: Pregabalin controlled release, 330 mg

Pregabalin immediate release, 150 mg

OTHER

Reference Treatment

Drug: Pregabalin immediate release, 150 mg

Interventions

Pregabalin controlled release, 165 mg DRUG

Two tablets of 165 mg controlled release (administered concurrently) once daily for four days.

Pregabalin controlled release, 165 mg

Pregabalin controlled release, 330 mg DRUG

330 mg controlled release tablet administered once daily for four days.

Pregabalin controlled release, 330 mg

Pregabalin immediate release, 150 mg DRUG

150 mg immediate release capsules administered every 12 hours for four days

Pregabalin immediate release, 150 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: September 14, 2010
• First Posted: September 15, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 22, 2021

Record last verified: 2010-12

Locations

BE (1)