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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 In Healthy Volunteers

NCT01220219 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-01-22

No results posted yet for this study

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

Interventions

DRUG

Pregabalin controlled release, 82.5 mg

Two tablets of 82.5 mg controlled release (administered concurrently) once daily for four days.

DRUG

Pregabalin controlled release, 165 mg

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

DRUG

Pregabalin immediate release, 75mg

75 mg immediate release capsule administered every 12 hours for four days

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01220219 on ClinicalTrials.gov