Comparison of Oxazepam 50 mg orodispersible tablets and Oxazepam 50 mg standard tablets in healthy volunteers to test if they work the same way in the body

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What is this study about?

This clinical trial compares two forms of oxazepam, a medication belonging to the benzodiazepine group of drugs. The study evaluates how the body processes a new orodispersible tablet form (dissolves in the mouth) compared to the standard tablet form of oxazepam. One medication is called Oxazepam 50 mg orodispersible tablets, and the other is Seresta 50 mg tablets.

The purpose of this study is to determine if both forms of the medication work similarly in the body. The study uses a crossover design, which means participants will receive both forms of the medication at different times. Both medications contain the same active ingredient and the same strength of 50 mg.

During the study, healthy participants will take a single dose of each medication form. Blood samples will be collected to measure how much of the medication enters the bloodstream and how long it stays in the body. The study also looks at how well participants tolerate the orodispersible tablet and monitors for any side effects. This is not a treatment study for any specific medical condition but rather a comparison of two different forms of the same medication.

1 Initial screening and qualification

You will undergo medical tests including blood tests for HIV, Hepatitis B, and Hepatitis C

A physical examination will be performed, including vital signs check and ECG (heart rhythm test)

Laboratory tests will be conducted to ensure your health status

A SARS-CoV-2 test will be performed or you will need to present a valid EU Digital COVID-19 Recovery Certificate

2 Study medication – Period 1

You will receive either:

– One 50 mg Oxazepam orodispersible tablet (dissolves in mouth) or

– One Seresta 50 mg tablet

After taking the orodispersible tablet, you will be asked about how it feels in your mouth after 30 seconds and 5 minutes

3 Washout period

A break period between taking the two different medications

4 Study medication – Period 2

You will receive the other medication that you did not take in Period 1:

– One 50 mg Oxazepam orodispersible tablet (dissolves in mouth) or

– One Seresta 50 mg tablet

After taking the orodispersible tablet, you will be asked about how it feels in your mouth after 30 seconds and 5 minutes

5 Monitoring throughout the study

Your health will be monitored through:

Regular checks of vital signs

ECG measurements

Blood tests

Recording of any side effects that may occur

Who Can Join the Study?

Must provide written consent before any study procedures begin
Must test negative for:
– HIV-1 and HIV-2 (viruses that affect the immune system)
– Hepatitis B (liver infection)
– Hepatitis C (liver infection)
Must be a non-smoker or have quit smoking for at least 3 months before screening
Must be willing to follow all study procedures and restrictions
For women:
– Must either be unable to have children, or
– If able to have children, must use approved birth control from 4 weeks before study starts until study ends
Must have negative SARS-CoV-2 (COVID-19) test or valid EU COVID-19 Recovery Certificate
Must be between 18 and 55 years old when signing consent
Must have a Body Mass Index (BMI) between 18.5 and 30.0 kg/m²
Must have a resting breathing rate between 8 and 20 breaths per minute
Must not have any significant medical conditions
Must have normal results from:
– Physical examination
– Vital signs (heart rate, blood pressure, temperature)
– ECG (heart rhythm test)
– Laboratory tests

Who Cannot Join the Study?

Age below 18 years or above 55 years
History of allergic reactions to any medications
Pregnant women or women planning pregnancy
Currently breastfeeding mothers
Participation in another clinical trial within the past 30 days
Current smokers or those who quit smoking less than 6 months ago
Presence of any significant medical conditions that could interfere with the study (such as heart, liver, or kidney problems)
Use of any prescription medications within 14 days before the study
Use of any over-the-counter medications within 7 days before the study
History of drug or alcohol abuse
Abnormal blood pressure readings (either too high or too low)
Body weight outside the normal BMI range (Body Mass Index: a measure of body fat based on height and weight)
Recent blood donation (within 3 months)
Any condition that could affect how the body processes medications
Unable to provide informed consent

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Brmbszcmxqjp Ivztmlxmoagq E Dgnjocwtnovnbgc Ea Srcpf Lqjs	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	12.10.2022

Trial locations

Investigated drugs:

Oxazepam

Oxazepam is an anti-anxiety medication that belongs to the benzodiazepine family. It helps reduce anxiety, tension, and agitation. The medication comes in an orodispersible tablet form, which means it dissolves quickly in the mouth without needing water. It is commonly used to treat anxiety disorders and can help with sleep problems.

Seresta (brand name for oxazepam) is a reference medication used to treat anxiety and tension. It is a traditional tablet form of oxazepam that has been well-established in medical practice. Like the test product, it belongs to the benzodiazepine family and works by calming the central nervous system to reduce anxiety symptoms.

Investigated diseases:

Anxiety

Based on the provided data, this is a bioequivalence study that does not investigate any specific medical condition. The study focuses on comparing drug products containing oxazepam, which belongs to the ATC code N05BA04 (benzodiazepine derivatives). Therefore, there are no specific diseases to describe in this case, as it is a comparative bioavailability study of pharmaceutical products rather than a disease-focused clinical trial.

If you need descriptions of conditions that oxazepam is typically used to treat, please let me know, and I can provide those using the requested format.

Trial ID:

2022-501135-16-00

Protocol code:

LESVIOXA/22/BQ-3

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Comparison of Oxazepam 50 mg orodispersible tablets and Oxazepam 50 mg standard tablets in healthy volunteers to test if they work the same way in the body

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?