An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule

NCT01009541 | Completed Phase 1

• 1 other identifier: A0081225
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three 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 three 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 (5)

• Area under the curve at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ

  5 days

• Minimum plasma concentration at steady-state within a dosing interval (Cmin)

  5 days

• Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax)

  5 days

• The average plasma concentration at steady-state (Cav), half-life

  5 days

• Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS)

  5 days

Secondary Outcomes (1)

• Safety endpoints include evaluation of adverse events.

  5 days

Study Arms (4)

Pregabalin controlled release, 82.5 mg

EXPERIMENTAL

Drug: Pregabalin controlled release, 82.5 mg

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, 82.5 mg DRUG

82.5 mg controlled release tablet administered once daily for three days.

Pregabalin controlled release, 82.5 mg

Pregabalin controlled release, 165 mg DRUG

165 mg controlled release tablet administered once daily for three days.

Pregabalin controlled release, 165 mg

Pregabalin controlled release, 330 mg DRUG

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

Pregabalin controlled release, 330 mg

Pregabalin immediate release, 150 mg DRUG

150 mg immediate release capsules administered every 12 hours for three 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, 1070, Belgium

Location

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: November 5, 2009
• First Posted: November 6, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 22, 2021

Record last verified: 2009-12

Locations

BE (1)