Therapeutic EquivalencyPhase 1NCT04468282
Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration
A Phase 1 study testing VGB-ST in people with Therapeutic Equivalency, run by Orphelia Pharma at 1 site in France.
Trial summary
Methodology: The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or Sabril, as single oral administration in 2 different study periods depending on the randomization, with a 7-days wash… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Equivalency
- What is being tested?
- VGB-ST
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2017to 8 Aug 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subject, aged between 18 and 50 years inclusive;
- Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm, condoms or abstinence) for the duration of the trial and for 1 month after the last study drug administration; Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhoea duration at least 12 months);
- Non breast-feeding female and negative pregnancy test at screening baseline;
- Non-smoker subject or smoker of not more than 5 cigarettes per day;
- Body Mass Index (BMI) between 18,5 and 25 kg/m2 inclusive;
- Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);
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- Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes in supine position
- Normal ECG recording on a 12-lead ECG at the screening visit
- Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests, urinalysis). Individual values out of the normal range could be accepted if judged clinically non relevant by the Investigator;
- Normal dietary habits;
- Signing a written informed consent prior to selection;
- Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
Who cannot join
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious disease or psychiatric disorders;
- Frequent headaches and / or migraine, recurrent nausea and / or vomiting;
- History of abnormal vision (e.g. reduced visual field, retinopathy, etc…);
- Abnormal visual field recorded during the inclusion period;
- Evidence of any clinically significant acute or chronic disease;
- Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position;
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- Surgery or blood donation (including in the frame of a clinical trial) within 2 months before administration;
- General anaesthesia within 3 months before administration;
- Presence or history of drug hypersensitivity, asthma or allergic disease diagnosed and treated by a physician;
- Inability to abstain from intensive muscular effort;
- No possibility of contact in case of emergency;
- Any drug intake (except paracetamol or contraception) during the last month prior to the first administration;
- History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day);
- Excessive consumption of beverages containing xanthine bases (> 4 cups or glasses / day);
- Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody (not including HSV), or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests;
- Positive results of screening for drugs of abuse;
- Subject who, in the judgment of the Investigator, was likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
- Exclusion period of a previous study;
- Administrative or legal supervision;
- Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study
Trial locations and contacts
1 site in 1 country.
About this study
Methodology:
The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or Sabril, as single oral administration in 2 different study periods depending on the randomization, with a 7-days wash out period between administrations
Read the detailed description
Objectives:
Primary objective:
Evaluate bioequivalence between a new paediatric formulation of vigabatrin (VGB-ST) and Sabril granules for oral administration.
Secondary objective:
- Define pharmacokinetic parameters of the new paediatric formulation soluble tablets of vigabatrin (VGB-ST)
- Assess the safety of the new formulation of soluble tablets VGB-ST versus Sabril
- Conditions
- Therapeutic Equivalency
- Being tested
- VGB-ST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VGB-STDrug
Also called vigabatrin soluble tablets, Kigabeq
Single oral administration of 500 mg VGB-ST
| Study group | Role | What they receive |
|---|---|---|
| VGB-ST | Experimental | Name of the compound: Vigabatrin ORPHELIA Pharma (VGB-ST) Pharmaceutical form: Soluble tablet Dose per administration: 500 mg Timing for administration: Single oral administration on P1D1 or P2D1 according to randomization.
Batch N°: 16.92.042 (expiry date: 31.05.2017) Receives: Drug: VGB-ST |
| Sabril | Active comparator | Name of the compound: Sabril (vigabatrin) Pharmaceutical form: granules (sachet) Dose per administration: 500 mg Timing for administration: Single oral administration on P1D1 or P2D1 according to randomization.
Batch N°: 6810 (expiry date: 31.05.2019) Receives: Drug: VGB-ST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary pharmacokinetic parameters (Bioequivalence)
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: Cmax
Measured: day 1 or 2
Primary pharmacokinetic parameters (Bioequivalence)
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: AUC0-t
Measured: day 1 or 2
Secondary outcomes (5)
Secondary pharmacokinetic parameters
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: AUC0-inf
Measured: day 1 or 2
Secondary pharmacokinetic parameters
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: tmax
Measured: day 1 or 2
Secondary pharmacokinetic parameters
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: λ
Measured: day 1 or 2
Secondary pharmacokinetic parameters
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: t1/2
Measured: day 1 or 2
Secondary pharmacokinetic parameters
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: residual area
Measured: day 1 or 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start4 Apr 2017
- Primary completion8 Aug 2017
- Study completion8 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic EquivalencyStudies of the same condition, open and under way.
- 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
- Model description
- The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or Sabril TM, as single oral administration in 2 different study periods depending on the randomization, with a 7-days wash out period between administrations.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orphelia Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PharmD PharmD, PhD, Study director, Orphelia Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468282
- Sponsor's protocol ID
- ORP-VGB-I-a
- Other IDs
- 2017-000038-67, 2017
- Status last verified
- Jul 2020
- First submitted
- 27 Mar 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration
- ClinicalTrials.gov ID
- NCT04468282
- Acronym / sponsor ID
- ORP-VGB-I-a
- Conditions
- Therapeutic Equivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Orphelia PharmaIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 13 Jul 2020 (actual)
- 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.
Methodology:
The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or Sabril, as single oral administration in 2 different study periods depending on the randomization, with a 7-days wash out period between administrations
Detailed description
Objectives:
Primary objective:
Evaluate bioequivalence between a new paediatric formulation of vigabatrin (VGB-ST) and Sabril granules for oral administration.
Secondary objective:
- Define pharmacokinetic parameters of the new paediatric formulation soluble tablets of vigabatrin (VGB-ST)
- Assess the safety of the new formulation of soluble tablets VGB-ST versus Sabril
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or Sabril TM, as single oral administration in 2 different study periods depending on the randomization, with a 7-days wash out period between administrations.
| Arm | Type | Receives |
|---|---|---|
| VGB-ST | Experimental | Drug: VGB-STName of the compound: Vigabatrin ORPHELIA Pharma (VGB-ST) Pharmaceutical form: Soluble tablet Dose per administration: 500 mg Timing for administration: Single oral administration on P1D1 or P2D1 according to randomization. Batch N°: 16.92.042 (expiry date: 31.05.2017) |
| Sabril | Active comparator | Drug: VGB-STName of the compound: Sabril (vigabatrin) Pharmaceutical form: granules (sachet) Dose per administration: 500 mg Timing for administration: Single oral administration on P1D1 or P2D1 according to randomization. Batch N°: 6810 (expiry date: 31.05.2019) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male and female subject, aged between 18 and 50 years inclusive;
- Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm, condoms or abstinence) for the duration of the trial and for 1 month after the last study drug administration; Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhoea duration at least 12 months);
- Non breast-feeding female and negative pregnancy test at screening baseline;
- Non-smoker subject or smoker of not more than 5 cigarettes per day;
- Body Mass Index (BMI) between 18,5 and 25 kg/m2 inclusive;
Key exclusion criteria (20 listed)
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious disease or psychiatric disorders;
- Frequent headaches and / or migraine, recurrent nausea and / or vomiting;
- History of abnormal vision (e.g. reduced visual field, retinopathy, etc…);
- Abnormal visual field recorded during the inclusion period;
- Evidence of any clinically significant acute or chronic disease;
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 |
|---|---|---|
| VGB-STAlso: vigabatrin soluble tablets, KigabeqSingle oral administration of 500 mg VGB-ST | Drug | Sabril, VGB-ST |
Primary outcome
Primary pharmacokinetic parameters (Bioequivalence)
Time frame: day 1 or 2
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: Cmax
Primary pharmacokinetic parameters (Bioequivalence)
Time frame: day 1 or 2
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: AUC0-t
5 secondary outcomes
Secondary pharmacokinetic parameters
Time frame: day 1 or 2
Secondary pharmacokinetic parameters
Time frame: day 1 or 2
Secondary pharmacokinetic parameters
Time frame: day 1 or 2
Secondary pharmacokinetic parameters
Time frame: day 1 or 2
Secondary pharmacokinetic parameters
Time frame: day 1 or 2
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 13 Jul 2020.
- Individual participant dataSharing planned: No
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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.
PharmD PharmD, PhD study director
Orphelia Pharma
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 VGB-ST in people with Therapeutic Equivalency, run by Orphelia Pharma at 1 site in France.
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 12 inclusion and 20 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 13 Jul 2020. 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 France. 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?
Primary pharmacokinetic parameters (Bioequivalence) (time frame: day 1 or 2). 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 13 Jul 2020.