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

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00987779

A9451168

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Period I: Tablet(400 mg single dose)

Experimental group

Description:

Period I: Tablet in fasting state, Period II: Liquid formulation in fasting state, Period III: Liquid formulation in fed state

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Period I: Liquid formulation(400 mg single dose)

Experimental group

Description:

Period I: Liquid formulation in fasting state, Period II: Tablet in fasting state, Period III: Liquid formulation in fed state

Treatment:

Drug: Gabapentin

Drug: Gabapentin