Epilepsy and Neuropathic PainPhase 1DRUG13-GABANCT01821235
Evaluation of Individual Bioequivalence of Gabasandoz® Relative to Neurontin® in Healthy Volunteers
A Phase 1 study testing Neurontin® (gabapentin) batch A, Neurontin® (gabapentin) batch B and Gabasandoz® (gabapentin) batch A in people with Epilepsy and Neuropathic Pain, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy and Neuropathic Pain
- What is being tested?
- Neurontin® (gabapentin) batch A, Neurontin® (gabapentin) batch B and Gabasandoz® (gabapentin) batch A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2013to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Single-blind, Randomized, Two-part, 6-way Cross-over Study to Investigate the Individual Bioequivalence of Gabasandoz® Relative to Neurontin® in Healthy Volunteers.
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.
Read the 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 ingredients with a narrow therapeutic index (i.e. small differences between the effective and toxic concentration), very toxic ingredients and all antiepileptics. For the active ingredients on the NO SWITCH-list, the FAMHP advises, once treatment is started with a medicines from a particular manufacturer, to continue treatment with exactly the same medicine (from the same manufacturer). In other words, switching from e.g. Neurontin® 800 mg to Gabasandoz® 800 mg during treatment is not recommended. However, switching is possible, but only when done carefully and under the supervision of a physician.
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.
This is a two-parted study. The first part is a 6 way crossover pilot study with 12 healthy volunteers (men and women). Data from this pilot study will be used to determine the following pharmacokinetic parameters: AUC0-t, AUC, Cmax and T1/2. The obtained data will be used to develop a Limited Sampling Strategy (LSS), i.e. a strategy to determine AUC and Cmax from a limited number of plasma concentrations. A simulation study will be performed, using data from the pilot study to determine the amount of volunteers needed to result into an appropriate statistical power. This simulation study will be performed according to the FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence2.
Part two of the study will be a 6 way crossover and AUC and Cmax will be determined using the developed Limited Sampled Strategy.
- Conditions
- Epilepsy and Neuropathic Pain
- Being tested
- Neurontin® (gabapentin) batch A, Neurontin® (gabapentin) batch B, Gabasandoz® (gabapentin) batch A, Gabasandoz® (gabapentin) batch B
- Medical subject headings
- Epilepsy, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurontin® (gabapentin) batch ADrug
Neurontin® 800 mg tablets (gabapentin) batch A, given 2 times
Neurontin® (gabapentin) batch BDrug
Neurontin® 800 mg tablets (gabapentin) batch B, given 1 time
Gabasandoz® (gabapentin) batch ADrug
Gabasandoz® 800 mg tablets (gabapentin) batch A, given 2 times
Gabasandoz® (gabapentin) batch BDrug
Gabasandoz® 800 mg tablets (gabapentin) batch A, given 1 time
| Study group | Role | What they receive |
|---|---|---|
| Neurontin® (gabapentin) batch A | Experimental | Not described Receives: Drug: Neurontin® (gabapentin) batch A |
| Neurontin® (gabapentin) batch B | Experimental | Not described Receives: Drug: Neurontin® (gabapentin) batch B |
| Gabasandoz® (gabapentin) batch A | Experimental | Not described Receives: Drug: Gabasandoz® (gabapentin) batch A |
| Gabasandoz® (gabapentin) batch B | Experimental | Not described Receives: Drug: Gabasandoz® (gabapentin) batch B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Neurontin® 800 mg
16 bloodsamples will be taken; Blood samples taken at 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 36h post-dose.
Measured: As of from dosing till 36 h postdose
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Gabasandoz® 800 mg
16 bloodsamples will be taken; Blood samples taken at 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 36h post-dose.
Measured: As of from dosing till 36 h postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy and Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, University Ghent
- Responsible party
- Sponsor
- Investigators
- Lucas Van Bortel, Phd, MD, Principal investigator, UZ Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821235
- Sponsor's protocol ID
- EC/2013/210
- Other IDs
- 2013-001157-27
- Acronym
- DRUG13-GABA
- Status last verified
- Jan 2014
- First submitted
- 26 Mar 2013
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Single-blind, Randomized, Two-part, 6-way Cross-over Study to Investigate the Individual Bioequivalence of Gabasandoz® Relative to Neurontin® in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01821235
- Acronym / sponsor ID
- DRUG13-GABA / EC/2013/210
- Conditions
- Epilepsy and Neuropathic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, University Ghent
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 29 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 ingredients with a narrow therapeutic index (i.e. small differences between the effective and toxic concentration), very toxic ingredients and all antiepileptics. For the active ingredients on the NO SWITCH-list, the FAMHP advises, once treatment is started with a medicines from a particular manufacturer, to continue treatment with exactly the same medicine (from the same manufacturer). In other words, switching from e.g. Neurontin® 800 mg to Gabasandoz® 800 mg during treatment is not recommended. However, switching is possible, but only when done carefully and under the supervision of a physician.
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.
This is a two-parted study. The first part is a 6 way crossover pilot study with 12 healthy volunteers (men and women). Data from this pilot study will be used to determine the following pharmacokinetic parameters: AUC0-t, AUC, Cmax and T1/2. The obtained data will be used to develop a Limited Sampling Strategy (LSS), i.e. a strategy to determine AUC and Cmax from a limited number of plasma concentrations. A simulation study will be performed, using data from the pilot study to determine the amount of volunteers needed to result into an appropriate statistical power. This simulation study will be performed according to the FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence2.
Part two of the study will be a 6 way crossover and AUC and Cmax will be determined using the developed Limited Sampled Strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neurontin® (gabapentin) batch A | Experimental | Drug: Neurontin® (gabapentin) batch A |
| Neurontin® (gabapentin) batch B | Experimental | Drug: Neurontin® (gabapentin) batch B |
| Gabasandoz® (gabapentin) batch A | Experimental | Drug: Gabasandoz® (gabapentin) batch A |
| Gabasandoz® (gabapentin) batch B | Experimental | Drug: Gabasandoz® (gabapentin) batch B |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurontin® (gabapentin) batch ANeurontin® 800 mg tablets (gabapentin) batch A, given 2 times | Drug | Neurontin® (gabapentin) batch A |
| Neurontin® (gabapentin) batch BNeurontin® 800 mg tablets (gabapentin) batch B, given 1 time | Drug | Neurontin® (gabapentin) batch B |
| Gabasandoz® (gabapentin) batch AGabasandoz® 800 mg tablets (gabapentin) batch A, given 2 times | Drug | Gabasandoz® (gabapentin) batch A |
| Gabasandoz® (gabapentin) batch BGabasandoz® 800 mg tablets (gabapentin) batch A, given 1 time | Drug | Gabasandoz® (gabapentin) batch B |
Primary outcome
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Neurontin® 800 mg
Time frame: As of from dosing till 36 h postdose
16 bloodsamples will be taken; Blood samples taken at 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 36h post-dose.
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Gabasandoz® 800 mg
Time frame: As of from dosing till 36 h postdose
16 bloodsamples will be taken; Blood samples taken at 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 36h post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas Van Bortel, Phd, MD principal investigator
UZ Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neurontin® (gabapentin) batch A, Neurontin® (gabapentin) batch B and Gabasandoz® (gabapentin) batch A in people with Epilepsy and Neuropathic Pain, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Neurontin® 800 mg (time frame: As of from dosing till 36 h postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.