Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

Area under the curve (AUC) from time zero (time of investigational medicinal product [IMP] administration) to the time of last measured concentration (AUC0-last), AUC from time zero (time of IMP administration) to infinity with extrapolation of the terminal phase (AUC0-inf) and maximum observed plasma concentration (Cmax) of Linalool

Secondary Outcomes (5)

Concentration at time (t) (Ct), extrapolation of AUC0-inf (AUCext), time to reach Cmax (tmax), terminal half-life (t1/2), time prior to the first measurable non-zero concentration (tlag) and terminal elimination rate constant (λz) of Linalool
Incidence, nature and severity of AEs and ADRs
AEs and ADRs leading to IMP/trial discontinuation
Serious AEs (SAEs) and serious ADRs (SADRs)
Changes in vital signs and physical examination

Interventions

HUILE ESSENTIELLE DE LAVANDE SCHWABE capsule molleType not reported

Silexan 80 mgType not reported

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Dr. Willmar Schwabe GmbH & Co. KG
Industrylead

Study Sites (1)

Biotrial

Rennes, 35000, France

Marina Klein0299599191 marina.klein@biotrial.com

Central Study Contacts

Susanne

+497214005508 susanne.kraft@schwabe.de

Study Design

Study Type: interventional
Phase: phase 1

Study Record Dates

First Submitted

April 17, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-503647-34-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 03:32:03 UTC

Documents

2023-503647-34-00_CSR_Synopsis_V1_29JAN2025_redacted

You may not qualify if:

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]].
+11 more criteria

A randomised, open-label, reference-replicated crossover trial to investigate the bioequivalence of two formulations of Silexan 80 mg in healthy volunteers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations