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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pregabalin controlled release, 330 mg; Drug: Pregabalin controlled release, 165 mg; Drug: Pregabalin immediate release, 150 mg

• Registration Number: NCT01202422
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule

Study Timeline

• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-15
• Study Start: 2010-10
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2010-12
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pregabalin controlled release, 330 mg	Pregabalin controlled release, 330 mg	-
Pregabalin controlled release, 165 mg	Pregabalin controlled release, 165 mg	-
Pregabalin immediate release, 150 mg	Pregabalin immediate release, 150 mg	Reference Treatment

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Safety endpoints include evaluation of adverse events.	5 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium