Status:
COMPLETED
Evaluation of Individual Bioequivalence of Gabasandoz® Relative to Neurontin® in Healthy Volunteers
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Amsterdam UMC, location VUmc
University Ghent
Conditions:
Epilepsy and Neuropathic Pain
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 (fr...
Detailed Description
At the end of 2011, the Belgian Federal Agency for Medicines and Health Products (FAMHP) introduced a list of medicines, called the 'NO SWITCH' list1. This list contains 42 active pharmaceutical ingre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01821235
Start Date
April 1 2013
End Date
November 1 2013
Last Update
January 29 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Drug Research Unit Ghent (D.R.U.G.)
Ghent, Belgium, 9000