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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy volunteers

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease

NCT00987779
Pfizer
Completed
Bioequivalence Study Of Gabapentin Between Tablet And Liquid Formulation And The Food Effect Study Of Liquid Formulation

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • 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
  • 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
    Intervention: Drug: Gabapentin
  • 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
    Intervention: Drug: Gabapentin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
October 2009
October 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT00987779
A9451168
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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