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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionHealthy
InterventionDrug: Gabapentin
Drug: Gabapentin
PhasePhase 1
SponsorPfizer
Responsible PartyPfizer
ClinicalTrials.gov IdentifierNCT00987779
First ReceivedSeptember 30, 2009
Last UpdatedSeptember 15, 2010
Last verifiedSeptember 2010

Tracking Information[ + expand ][ + ]

First Received DateSeptember 30, 2009
Last Updated DateSeptember 15, 2010
Start DateOctober 2009
Estimated Primary Completion DateOctober 2009
Current Primary Outcome MeasuresPharmacokinetic (PK) Endpoints - Primary: plasma Cmax and AUCt of gabapentin. - Secondary: plasma AUCinf, AUClast, Tmax, kel, MRT and t1/2 of gabapentin [Time Frame: dosing to 3 days] [Designated as safety issue: Yes]
Current Secondary Outcome MeasuresSafety Endpoints - Adverse events and safety laboratory data [Time Frame: dosing to 3 days] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleBioequivalence Study Of Gabapentin Between Tablet And Liquid Formulation And The Food Effect Study Of Liquid Formulation
Official TitleAn 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
Brief 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionHealthy
InterventionDrug: 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
Study Arm (s)
  • Experimental: Period I: Tablet(400 mg single dose)
    Period I: Tablet in fasting state, Period II: Liquid formulation in fasting state, Period III: Liquid formulation in fed state
  • Experimental: Period I: Liquid formulation(400 mg single dose)
    Period I: Liquid formulation in fasting state, Period II: Tablet in fasting state, Period III: Liquid formulation in fed state

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment26
Estimated Completion DateOctober 2009
Estimated Primary Completion DateOctober 2009
Eligibility Criteria
Inclusion Criteria:

- Healthy volunteers

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease
GenderBoth
Ages21 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesSingapore

Administrative Information[ + expand ][ + ]

NCT Number NCT00987779
Other Study ID NumbersA9451168
Has Data Monitoring CommitteeNo
Information Provided ByPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators Study Director: Pfizer CT.gov Call Center Pfizer
Verification DateSeptember 2010

Locations[ + expand ][ + ]

Pfizer Investigational Site
Singapore, Singapore, 188770