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Evaluation of Individual Bioequivalence of Gabasandoz® Relative to Neurontin® in Healthy Volunteers

NCT01821235 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2014-01-29

No results posted yet for this study

Summary

The NO SWITCH list is based on the hypothesis that the pharmacokinetic differences between different batches of one medicines are smaller than the pharmacokinetic differences between two medicines (from a different manufacturer, e.g. brand versus generic medicine). The aim of this study is to investigate the hypothesis using gabapentin as test product. Therefore, the first objective of this study is to investigate the individual bioequivalence - or switchability - of Gabasandoz® 800 mg relative to Neurontin 800 mg®. The second objective is to investigate the individual bioequivalence between two different batches of the same medicine, for Gabasandoz® 800 mg and Neurontin® 800 mg.

Conditions

  • Epilepsy and Neuropathic Pain

Interventions

DRUG

Neurontin® (gabapentin) batch A

Neurontin® 800 mg tablets (gabapentin) batch A, given 2 times

DRUG

Neurontin® (gabapentin) batch B

Neurontin® 800 mg tablets (gabapentin) batch B, given 1 time

DRUG

Gabasandoz® (gabapentin) batch A

Gabasandoz® 800 mg tablets (gabapentin) batch A, given 2 times

DRUG

Gabasandoz® (gabapentin) batch B

Gabasandoz® 800 mg tablets (gabapentin) batch A, given 1 time

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • University Ghent

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Lucas Van Bortel, Phd, MD · UZ Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01821235 on ClinicalTrials.gov