Bioequivalence Study of Two Silexan 80 mg Formulations in Healthy Volunteers: A Randomized, Open-Label, Reference-Replicated Crossover Trial
- Trial ID
- 2023-503647-34-00
- Protocol
- D.01.01.2.03
Trial statistics
Objectives
The primary objective of this study is to evaluate the **bioequivalence** of two formulations of Silexan 80 mg in healthy volunteers. Bioequivalence studies are crucial in determining whether different formulations of a drug release the active ingredient into the bloodstream at the same rate and extent, ensuring therapeutic equivalence. This is particularly important for maintaining consistent efficacy and safety profiles across different formulations of the same medication.
Participants
The clinical trial involves **healthy volunteers** as the study population, encompassing both male and female participants. The age range of the participants is categorized as adults, although specific age details are not provided. The trial does not focus on a vulnerable population, and the selection criteria for participants have not been disclosed by the sponsor. Additionally, the total number of participants involved in the study has not been specified. There are no specific lifestyle considerations such as diet, physical activity, or habits mentioned in the available data. The sponsor has not provided detailed information regarding key inclusion or exclusion criteria for this trial.
Plans and Procedures
The clinical trial is designed as a **randomized**, open-label, reference-replicated crossover study aimed at investigating the bioequivalence of two formulations of Silexan 80 mg in **healthy volunteers**. The trial is categorized under Phase 2 and is expected to commence recruitment on June 30, 2023, with an estimated completion date of October 11, 2023. The study involves a sequence of visits, beginning with an inclusion visit where participants are screened for eligibility based on predefined criteria. This is followed by a series of study visits where participants receive the investigational product according to the crossover design, allowing each participant to receive both formulations in a randomized order. The purpose of these visits is to collect data on the pharmacokinetic parameters of the formulations to assess bioequivalence.
Participants are expected to be involved in the study for the duration of the trial, from the initial screening to the end-of-study visit. The end-of-study visit will involve final assessments to ensure participant safety and to gather any remaining data required for the study's objectives. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial's design and procedures are structured to ensure the collection of robust data while maintaining participant safety and adherence to ethical standards.
Treatment
No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.
Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.
Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.
Efficacy
The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on June 30, 2023, with an estimated end date of October 11, 2023. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy evaluation are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methods and tools for measuring efficacy, as well as the specific timepoints for these assessments, are not specified in the provided information. The trial's focus on efficacy is aligned with the objectives typical of Phase 2 studies, which often aim to evaluate the effectiveness of a treatment in a specific patient population. The trial's design and execution will adhere to rigorous standards to ensure the reliability and validity of the efficacy data collected.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Healthy based on specified criteria evaluated at the screening visit (physical examination, ECG, vital signs, safety laboratory).
- Male and female aged ≥ 18 years to ≤ 55 years old on the day of signing the informed consent.
- Body mass index (BMI) of ≥ 18.00 to ≤ 30.00 kg/m2, with body weight ≥ 50.00 kg at screening and D-1.
- Vital sign results in normal ranges at screening and D-1. If outside normal ranges, must be considered by the investigator without clinically significant abnormal findings.
- Physical examination results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day −1.
- Signed informed consent in accordance with the legal requirements prior to any other trial procedures.
- Volunteers must agree to comply with the trial protocol (hospitalisation periods, scheduled visits, treatment plan, clinical laboratory tests, and other trial procedures including lifestyle considerations).
- Be affiliated with a Social Security System.
- Have competence in speaking, writing, and comprehending the local language(s) where the trial is conducted.
Exclusion Criteria
- Participation in a further CT at the same time or in the exclusion period of a previous trial before screening.
- Female volunteers: Pregnancy or lactation.
- Volunteers not using adequate contraception, defined as one of the following: a. Women having at least 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., appropriate age). b. Women with history of hysterectomy or surgical removal of both ovaries. OR Female volunteers of childbearing potential who agree to use at least two forms of appropriate contraception methods (e.g., established use of oral, injected, intravaginal, transdermal, or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine hormone-releasing system, physical barrier [Note: Female condom and male condom should not be used together]) from Screening until the EOT. Female volunteers of childbearing potential with a sole vasectomised male partner will be allowed. Vasectomised partners should be medically confirmed for sterilisation. True abstinence alone will be allowed if this is in line with the preferred and usual lifestyle of the volunteer, or for volunteers who do not have a partner. Contraceptive methods do not apply for volunteers whose partner is of the same gender.
- Positive pregnancy test.
- Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g., partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea).
- Any condition which constitutes a contra-indication for treatment with Silexan (hypersensitivity to the active substance or to any of the excipients, patients with impairment of hepatic function).
- Hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
- History and/or current presence of clinically significant atopic allergy, hypersensitivity, or allergic reactions (either spontaneous or following drug administration).
- History of and/or current clinically significant renal, hepatic, cardiovascular, haematological, respiratory, neurologic, metabolic, psychiatric disorder, drug or alcohol abuse, or allergic disease excluding mild asymptomatic seasonal allergies.
- History of malignancy (including lymphoma, leukaemia, and skin cancer).
- Presence of any possibly relevant active co-morbidity (including conditions that might affect absorption, distribution and elimination of the investigational compounds, acute or chronic infections).
- Use of any prescription drugs within 4 weeks prior to first dosing, or over the counter medication (e.g., vitamins, herbal supplements, St. John’s wort, dietary supplements) within 5 days prior to first dosing (14 days for compounds with a half-life longer than 24 hours). Paracetamol is acceptable, if allowed by the Investigator, up to 3 intakes of 500 mg per day.
- Presence of any possibly confounding clinical laboratory at screening including but not confined to abnormal values for complete blood count, coagulation, serology and clinical chemistry, if assessed as clinically relevant by the Investigator.
- Positive test for human immunodeficiency virus (HIV 1 and 2) antibodies, hepatitis B-virus surface antigen (HbsAg), or anti-hepatitis C virus antibodies (anti-HCV) at screening.
- Positive test for blood in urine at screening and D-1 (except due to menses in female volunteers), if considered “clinically significant” by the Investigator.
- Relevant abnormality in 12-lead ECG at screening including, but not confined to prolonged heart rate (HR)-controlled QTc (normal ranges: QT interval corrected using Fridericia’s formula [QTcF) ≤ 450 ms [male volunteers] or ≤ 470 ms [female volunteers]].
- Surgery (including invasive dental treatment or dental surgery) done within one month prior to randomisation, and/or plan to have an operation during the trial period.
- History and/or current presence of an illness within 14 days prior to randomisation that is classified as clinically significant by the Investigator.
- Smoking of any kind within the last 3 months.
- Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day).
- Daily use of ≥ 24 g (men)/ ≥ 12 g (women) of pure alcohol regularly per day (12 g = 1 unit).
- Positive urinary drug screening or alcohol breath test at Screening or D-1.
- Trial personnel or first-degree relatives of investigators.
- Have donated > 450 mL blood or plasma within 28 days prior to D1.
- Known or suspected not to be reliable, or unwilling or unable to adhere to the trial directives and restrictions
- Vulnerable volunteers (e.g., persons kept in detention).
- Any condition in the opinion of the Investigator that may jeopardise a safe trial participation.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 France | Not Recruiting | 30 Jun 2023 | 92 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
HUILE ESSENTIELLE DE LAVANDE SCHWABE capsule molle | Comparator | CAPSULE MOLLE | ORAL | 80 | 2 | PRD7648018 |
Silexan 80 mg | Test | GASTRO-RESISTANT CAPSULE, SOFT | ORAL | 80 | 2 | PRD10243484 |