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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Ghent
• Collaborators: University Ghent; VU University Medical Center
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

• Healthy males and females aged between 18 and 55 years at screening, extremes included.

• A Body Mass Index of 18.0 to 30.0 kg/m².

• Good physical and mental health.

• Subject is a non-smoker for at least 3 months prior to dosing.

Exclusion Criteria:

• Clinically relevant abnormal laboratory, ECG recordings, vital signs or physical findings at screening as judged by the investigator.

• History of hypersensitivity or idiosyncrasy to gabapentin or any other anti-convulsive agents.

• Positive serology for hepatitis B antigen, hepatitis C antibodies, HIV 1 or HIV 2 antibodies.

• History of alcohol or drug abuse within the last 2 years.

• Blood donation within 1 month before screening.

• Female subjects who are pregnant or lactating.