Study on the Bioequivalence of Oxazepam 10 mg Orodispersible Tablets Compared to Standard Tablets in Healthy Volunteers

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What is this study about?

This clinical trial is focused on comparing two forms of the medication Oxazepam, which is commonly used to treat anxiety. The study involves Oxazepam 10 mg orodispersible tablets and Seresta 10 mg tablets. The purpose of the study is to compare how the body absorbs these two forms of the medication and to determine if they are equivalent in terms of their effects.

The study is designed as a single-dose, open-label trial, meaning that participants will know which form of the medication they are taking. It involves healthy individuals who will receive both forms of the medication at different times. Participants will take the medication orally, and the study will observe how the body processes each form. The trial will also assess the safety of the medications by monitoring any side effects and checking vital signs, such as heart rate and blood pressure.

Additionally, the study will evaluate the taste and ease of use of the orodispersible tablet form. This involves placing the tablet on the tongue and assessing its palatability shortly after. The trial aims to provide valuable information on whether the two forms of Oxazepam are interchangeable, which could help inform future treatment options for patients requiring this medication.

1 initial visit

Upon joining the study, participants will attend an initial visit. During this visit, participants will receive detailed information about the study and will be asked to provide informed consent to participate.

Participants will undergo a series of tests to confirm eligibility, including tests for HIV, Hepatitis B, and Hepatitis C. A COVID-19 test or a valid recovery certificate will also be required.

Participants will be assessed to ensure they meet the study’s criteria, such as age, body mass index, and health status.

2 first treatment period

Participants will be randomly assigned to receive either the test product (Oxazepam 10 mg orodispersible tablet) or the reference product (Seresta 10 mg tablet).

The medication will be taken orally as a single dose. Participants will be monitored for any immediate reactions and will be asked to assess the taste of the orodispersible tablet approximately 30 seconds and 5 minutes after taking it.

Participants will remain under observation for a specified period to monitor for any adverse effects and to collect data on how the body absorbs the medication.

3 washout period

After the first treatment period, there will be a washout period. This is a break between treatments to ensure that the first medication is completely cleared from the body before the next treatment begins.

The duration of the washout period will be determined by the study protocol.

4 second treatment period

Participants will switch to the other medication they did not receive during the first treatment period. If the test product was taken first, the reference product will be taken now, and vice versa.

The same procedures as in the first treatment period will be followed, including taking the medication as a single dose, monitoring for reactions, and assessing the taste of the orodispersible tablet.

Participants will again be observed for a specified period to collect data on the medication’s absorption and any adverse effects.

5 final assessment

At the end of the study, participants will undergo a final assessment. This will include a review of any adverse events, a check of vital signs, and laboratory tests to ensure safety.

Participants will have the opportunity to discuss their experience and provide feedback on the study.

Who Can Join the Study?

Provide free written informed consent before any study procedures. This means you agree to participate after understanding the study details.
Have negative test results for:
- HIV (Human Immunodeficiency Virus) types 1 and 2
- Hepatitis B surface antigen
- Hepatitis C virus antibodies
Be a non-smoker or an ex-smoker. An ex-smoker is someone who has not used tobacco or nicotine products for at least 3 months before the study.
Be willing to accept and follow all study procedures and restrictions.
If you are a female participant, you must either:
- Be of non-childbearing potential, or
- Be of childbearing potential and agree to use an accepted contraceptive method from at least 4 weeks before the study until the end of the study.
Have a negative SARS-CoV-2 test or a valid EU Digital COVID-19 Recovery Certificate.
Be a male or female aged between 18 and 55 years at the time of signing the informed consent.
Have a Body Mass Index (BMI) between 18.5 and 30.0 kg/m². BMI is a measure of body fat based on height and weight.
Have a resting respiratory rate between 8 and 20 breaths per minute. This is the number of breaths you take while at rest.
Have no clinically relevant diseases in your medical history.
Have no clinically relevant abnormalities during a physical examination.
Have no clinically relevant abnormalities in vital signs, which include measurements like blood pressure and heart rate.
Have no clinically relevant abnormalities on a 12-lead ECG, which is a test that checks your heart’s electrical activity.
Have no clinically relevant abnormalities in clinical laboratory tests, which are tests done on samples of your blood, urine, or other tissues.

Who Cannot Join the Study?

Participants must not have any serious health conditions that could affect the study.
Participants should not be taking any medications that might interfere with the study results.
Participants must not have a history of allergic reactions to the study products.
Participants should not be pregnant or breastfeeding.
Participants must not have participated in another clinical trial recently.
Participants should not have any condition that makes it unsafe for them to participate, as determined by the study doctor.
Participants must not have a history of drug or alcohol abuse.
Participants should not have any mental health conditions that could affect their ability to follow study instructions.

Where you can join this trial?

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Site Name	City	Country	Status
Bywcnnhmaljr Ixlomwjqdwkx E Dgrkmywpsxcmhhk Ew Sxjtf Lhce	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	03.10.2022

Trial locations

Investigated drugs:

Oxazepam

Oxazepam is a medication that is often used to help with anxiety and sometimes to treat symptoms of alcohol withdrawal. In this clinical trial, the focus is on a special form of Oxazepam that dissolves quickly in the mouth, known as an orodispersible tablet. This form is designed to make it easier to take, especially for people who might have trouble swallowing pills. The trial aims to see how this form of Oxazepam is absorbed in the body compared to a standard tablet form.

Seresta is the brand name for a standard tablet form of Oxazepam. It is used as a reference in this trial to compare how the body absorbs it versus the new orodispersible form of Oxazepam. By comparing these two forms, researchers hope to determine if the new form works just as well as the standard tablet in terms of how much of the medication gets into the bloodstream and how quickly it does so.

Investigated diseases:

Anxiety

No medical condition is being investigated – This study is focused on comparing the bioavailability and assessing the bioequivalence of a test product versus a reference product. It does not involve the investigation of any specific medical condition. The primary focus is on pharmacokinetic parameters such as Cmax and AUC0-t of oxazepam. Safety evaluations are conducted through the assessment of adverse events, ECG, vital signs, and clinical laboratory tests. Additionally, the palatability of the test product is assessed shortly after administration.

Trial ID:

2022-501134-35-00

Protocol code:

LESVIOXA/22/BQ-2

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Study on the Bioequivalence of Oxazepam 10 mg Orodispersible Tablets Compared to Standard Tablets in Healthy Volunteers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?