NCT00987779

Bioequivalence Study Of Gabapentin Between Tablet And Liquid Formulation And The Food Effect Study Of Liquid Formulation

An Open, Randomized, Crossover Study In Healthy Subjects To Assess The Bioequivalence Of Gabapentin Between Japanese Commercial Tablet And Japanese Commercial Image Liquid Formulation And The Effect Of Food On The Pharmacokinetics Of Japanese Commercial Image Liquid Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Primary objective for this study is to demonstrate bioequivalence between Japanese commercial tablet and Japanese commercial image liquid formulation. Secondary objective for this study is to estimate the food effect for Japanese commercial image liquid formulation.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Gabapentin	Period I: Tablet in fasting state(400 mg single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: Liquid formulation in fasting state(400 mg single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period III: Liquid formulation(400 mg single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period) in fed state
DRUG	Gabapentin	Period I: Liquid formulation in fasting state(400 mg single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: Tablet in fasting state(400 mg single doseon Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period III: Liquid formulation(400 mg single doseon Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period) in fed state

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-10-01
• Last updated: 2021-02-02

Locations

1 site across 1 country: Singapore