Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration

July 8, 2020 updated by: Orphelia Pharma

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Gières, France, 38610
        • Eurofins Optimed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy male and female subject, aged between 18 and 50 years inclusive;
  2. 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);
  3. Non breast-feeding female and negative pregnancy test at screening baseline;
  4. Non-smoker subject or smoker of not more than 5 cigarettes per day;
  5. Body Mass Index (BMI) between 18,5 and 25 kg/m2 inclusive;
  6. Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);
  7. Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes in supine position
  8. Normal ECG recording on a 12-lead ECG at the screening visit
  9. 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;
  10. Normal dietary habits;
  11. Signing a written informed consent prior to selection;
  12. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Exclusion Criteria:

  1. Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious disease or psychiatric disorders;
  2. Frequent headaches and / or migraine, recurrent nausea and / or vomiting;
  3. History of abnormal vision (e.g. reduced visual field, retinopathy, etc…);
  4. Abnormal visual field recorded during the inclusion period;
  5. Evidence of any clinically significant acute or chronic disease;
  6. 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;
  7. Surgery or blood donation (including in the frame of a clinical trial) within 2 months before administration;
  8. General anaesthesia within 3 months before administration;
  9. Presence or history of drug hypersensitivity, asthma or allergic disease diagnosed and treated by a physician;
  10. Inability to abstain from intensive muscular effort;
  11. No possibility of contact in case of emergency;
  12. Any drug intake (except paracetamol or contraception) during the last month prior to the first administration;
  13. History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day);
  14. Excessive consumption of beverages containing xanthine bases (> 4 cups or glasses / day);
  15. 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;
  16. Positive results of screening for drugs of abuse;
  17. 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;
  18. Exclusion period of a previous study;
  19. Administrative or legal supervision;
  20. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VGB-ST

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)
Drug: VGB-ST
Single oral administration of 500 mg VGB-ST
Other Names:
  • vigabatrin soluble tablets
  • Kigabeq
Active Comparator: Sabril

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)
Drug: VGB-ST
Single oral administration of 500 mg VGB-ST
Other Names:
  • vigabatrin soluble tablets
  • Kigabeq

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary pharmacokinetic parameters (Bioequivalence)
Time Frame: day 1 or 2
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: Cmax
day 1 or 2
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
day 1 or 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary pharmacokinetic parameters
Time Frame: day 1 or 2
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: AUC0-inf
day 1 or 2
Secondary pharmacokinetic parameters
Time Frame: day 1 or 2
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: tmax
day 1 or 2
Secondary pharmacokinetic parameters
Time Frame: day 1 or 2
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: λ
day 1 or 2
Secondary pharmacokinetic parameters
Time Frame: day 1 or 2
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: t1/2
day 1 or 2
Secondary pharmacokinetic parameters
Time Frame: day 1 or 2
The following pharmacokinetic parameters were determined from S(+) enantiomer of vigabatrin plasma concentrations: residual area
day 1 or 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orphelia Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: PharmD PharmD, PhD, Orphelia Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ORP-VGB-I-a
  • 2017-000038-67 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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