Comparative Bioavailability and Bioequivalence of Oxazepam 10 mg Orodispersible Tablets (Test) Versus Seresta® 10 mg Tablets (Reference): A Single-Dose, Open-Label, Randomized, Two-Sequence, Two-Treatment, Two-Period Crossover Study in Healthy Subjects

Trial ID: 2022-501134-35-00
Protocol: LESVIOXA/22/BQ-2
Sponsor: Neuraxpharm Pharmaceuticals S.L.

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Diseases & Conditions

Anxiety Delirium tremens

Objectives

The primary objective of this study is to evaluate the **bioequivalence** of Oxazepam 10 mg orodispersible tablets compared to Seresta® 10 mg tablets in healthy subjects. This is a comparative bioavailability study, which is crucial for determining whether the new formulation of Oxazepam provides the same therapeutic effect and safety profile as the established Seresta® tablets. Establishing bioequivalence is essential for ensuring that patients receive consistent and effective treatment when switching between different formulations of the same medication.

Participants

The clinical trial involves a **comparative bioavailability study** with no specific medical condition being investigated. The study population includes both male and female participants, encompassing an **age range** of adults. The trial population selection criteria and the total number of participants have not been disclosed by the sponsor. The study includes a vulnerable population, although specific details regarding lifestyle considerations such as diet, physical activity, or habits have not been provided. The sponsor has not given information on key inclusion or exclusion criteria.

Plans and Procedures

The clinical trial is designed to assess the **bioequivalence** of Oxazepam 10 mg orodispersible tablets compared to Seresta® 10 mg tablets in healthy subjects. This is a Phase 2, randomized, double-blind, controlled study with no specific medical condition being investigated, as it is a comparative bioavailability study. The trial is expected to commence recruitment on October 3, 2022, and conclude by October 21, 2022, indicating a short overall trial duration.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the test or reference product. The study will include multiple follow-up visits to monitor the pharmacokinetic parameters and ensure participant safety. The end-of-study visit will involve final assessments and data collection to evaluate the primary and secondary endpoints of the trial.

The expected length of participant involvement is approximately three weeks, from the initial screening to the end-of-study visit. 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 is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the integrity and reliability of the data collected.

Treatment

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

Efficacy

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial's estimated recruitment start date is October 3, 2022, with an estimated end date of October 21, 2022. The efficacy assessment will be conducted through a series of planned methods and schedules, although specific parameters or endpoints used to evaluate efficacy, such as symptom improvement scores, biomarker levels, or disease remission rates, are not detailed in the provided data. The trial will follow a structured approach to measure, collect, and analyze these efficacy parameters, ensuring that the data collected is robust and reliable. The trial phase indicates a focus on evaluating the effectiveness of the intervention, which is typical for Phase 2 studies. The trial will adhere to rigorous standards to ensure the validity and reliability of the efficacy assessments, although specific tools or instruments involved in these assessments are not mentioned in the available information.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Free written informed consent prior to any procedure required by the study.
Male or female subject between 18 and 55 years, inclusive, at the time of signing the informed consent.
Body mass index (BMI) of 18.5 to 30.0 kg/m2, inclusive.
Resting respiratory rate between 8 and 20 cpm, inclusive.
No clinically relevant diseases captured in medical history.
No clinically relevant abnormalities on physical examination.
No clinically relevant abnormalities on vital signs.
No clinically relevant abnormalities on 12-lead ECG.
No clinically relevant abnormalities on clinical laboratory tests.
Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg) and anti- Hepatitis C virus antibodies (anti-HCVAb).
Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).
Willingness to accept and comply with all study procedures and restrictions.
A female subject is eligible if she meets one of the following criteria: a) is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted contraceptive method from at least 4 weeks prior to admission to the first treatment period until at least the end-of-study.
Negative SARS-CoV-2 test or valid EU Digital COVID-19 Recovery Certificate.

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Exclusion Criteria

Known hypersensitivity/allergy reaction to the study drug substance or any of the excipients.
Known rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption
Known severe hypersensitivity reaction to any other drug.
Any medical condition (e.g. gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g. cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject safety.
History of respiratory insufficiency or sleep apnea.
History of myasthenia.
History of opioid, alcohol, or other drug dependence (excluding nicotine and caffeine).
History of psychiatric disorder.
Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
Estimated renal creatinine clearance (CrCL) below 90 mL/min, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average surface area of 1.73 m2.
Positive result in drugs-of-abuse or ethanol tests.
Use of a depot injection or an implant of any drug (all but contraceptives) within the previous 6 months.
Average weekly alcohol consumption of >14 units for males and >7 units for females within the previous 6 months.
Average daily consumption of methylxanthines-containing beverages or food (e.g. coffee, tea, cola, sodas, chocolate) equivalent to >500 mg methylxanthines
Participation in any clinical trial within the previous 2 months.
Participation in more than 2 clinical trials within the previous 12 months.
Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
Difficulty in fasting or any dietary restriction such as lactose intolerance, vegan, lowfat, low sodium, etc., that may interfere with the diet served during the study.
Veins unsuitable for intravenous puncture on either arm.
Difficulty in swallowing capsules or tablets.
For female subjects, positive pregnancy test in serum.
For female subjects, subject is breast-feeding.
Any other condition that the investigator considers rendering the subject unsuitable for the study.
Any recent disease or condition or treatment that, according to the investigator, would put the subject at undue risk due to study participation or occurred at a timeframe in which may interfere with the pharmacokinetics of study drug.
Use of prescription or nonprescription medicinal products (such as vitamins, food supplements and herbal supplements, including St John's Wort) within the previous 2 weeks, unless in the investigator's opinion the medication does not interfere with the pharmacokinetics of study drug or compromise subject safety.
Use of morphine derivatives (analgesics, antitussives or opioid substitution treatments), neuroleptics, barbiturics, other anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, central antihypertensives, baclofen or thalidomide within the previous 4 weeks.
Consumption of pineapple, Seville oranges, pomelo, pomegranate, starfruit or grapefruit products (fresh, canned, or frozen) within the previous 7 days.
Positive result in drugs-of-abuse or ethanol tests.
For female subjects, positive pregnancy test.
Any other condition that the investigator considers rendering the subject unsuitable for the study period.