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NCT00987779 Clinical Trial

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

Healthy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00987779
Other study ID # A9451168
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2009
Est. completion date October 2009

Study information
Verified date September 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility Inclusion Criteria: - Healthy volunteers Exclusion Criteria: - Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

Study Design

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
Singapore Pfizer Investigational Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic (PK) Endpoints - Primary: plasma Cmax and AUCt of gabapentin. - Secondary: plasma AUCinf, AUClast, Tmax, kel, MRT and t1/2 of gabapentin dosing to 3 days
Secondary Safety Endpoints - Adverse events and safety laboratory data dosing to 3 days
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