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. |
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Condition | Healthy |
Intervention | Drug: Gabapentin Drug: Gabapentin |
Phase | Phase 1 |
Sponsor | Pfizer |
Responsible Party | Pfizer |
ClinicalTrials.gov Identifier | NCT00987779 |
First Received | September 30, 2009 |
Last Updated | September 15, 2010 |
Last verified | September 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | September 30, 2009 |
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Last Updated Date | September 15, 2010 |
Start Date | October 2009 |
Estimated Primary Completion Date | October 2009 |
Current Primary Outcome Measures | Pharmacokinetic (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 Measures | Safety Endpoints - Adverse events and safety laboratory data [Time Frame: dosing to 3 days] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Bioequivalence Study Of Gabapentin Between Tablet And Liquid Formulation And The Food Effect Study Of Liquid Formulation |
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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 |
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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Healthy |
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 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 26 |
Estimated Completion Date | October 2009 |
Estimated Primary Completion Date | October 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 |
Gender | Both |
Ages | 21 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Singapore |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00987779 |
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Other Study ID Numbers | A9451168 |
Has Data Monitoring Committee | No |
Information Provided By | Pfizer |
Study Sponsor | Pfizer |
Collaborators | Not Provided |
Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
Verification Date | September 2010 |
Locations[ + expand ][ + ]
Pfizer Investigational Site | Singapore, Singapore, 188770 |
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