Study on How Minzasolmin is Absorbed in the Body and its Safety in Healthy Adults

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What is this study about?

This clinical trial is focused on understanding how the body absorbs a medication called Minzasolmin when taken in different forms and how food might affect its absorption. The study involves healthy adults and aims to compare a new tablet form of Minzasolmin with an existing capsule form. The purpose is to estimate how much of the drug enters the bloodstream in these different forms and conditions.

Participants in the study will take Minzasolmin in both tablet and capsule forms. The study will observe how the drug is absorbed when taken on an empty stomach and after eating. This will help researchers understand the best way to take Minzasolmin for optimal absorption. The study will also monitor for any side effects that may occur during the trial.

The trial is designed to ensure the safety of participants while gathering important information about Minzasolmin. By comparing the different forms and conditions, researchers hope to determine the most effective way to administer the medication. The study will provide valuable insights into the drug’s behavior in the body, contributing to its safe and effective use in the future.

1 joining the study

Upon joining the study, you will be asked to sign an informed consent form. This form confirms that you understand the study and agree to participate.

You must be between 18 and 55 years old, in good health, and meet specific weight and body mass index criteria.

2 initial assessment

A medical evaluation will be conducted, including a review of your medical history, a physical examination, laboratory tests, and heart monitoring to ensure you are healthy.

3 medication administration

You will receive two different forms of the medication minzasolmin: a film-coated tablet and a capsule.

The study will assess how much of the medication enters your body when taken in these forms and how food affects this process.

4 taking the medication

You will take the minzasolmin tablet and capsule orally. The study will involve taking the medication under both fasted and fed conditions to evaluate the effect of food.

The exact dosage, frequency, and duration of administration will be provided by the study team.

5 monitoring and follow-up

Throughout the study, your health will be closely monitored. This includes measuring the concentration of minzasolmin in your blood at various times.

You will be observed for any side effects or adverse reactions to the medication.

6 completion of the study

At the end of the study, a final assessment will be conducted to ensure your well-being.

You will be informed about the study’s findings and any relevant information regarding your participation.

Who Can Join the Study?

Participant must be between 18 to 55 years old at the time of signing the informed consent form.
Participants should be overtly healthy, meaning they should not have any noticeable health issues. This will be determined by a medical evaluation, which includes checking medical history, a physical examination, laboratory tests, and heart monitoring.
Body weight should be between 45 to 100 kg for females and 50 to 100 kg for males.
Body mass index (BMI) should be within the range of 18 to 30 kg/m². BMI is a measure that uses your height and weight to work out if your weight is healthy.

Who Cannot Join the Study?

Participants must be healthy. This means they should not have any ongoing medical conditions.
Participants must be within a certain age range. This study is for adults only.
Both men and women can participate.
Participants should not be part of a vulnerable population. This means they should not be in a situation where they are unable to make decisions for themselves.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
PAREXEL International GmbH	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	25.09.2024

Trial locations

Investigated drugs:

Minzasolmin

Minzasolmin is a medication being tested in this clinical trial. The study is looking at how well a new tablet form of Minzasolmin is absorbed by the body compared to an older form that comes as granules in a capsule. The trial also examines if eating food affects how the new tablet form of Minzasolmin is absorbed. This information helps researchers understand the best way to take Minzasolmin for it to work effectively in the body.

Healthy Participants – This term refers to individuals who do not have any diagnosed medical conditions or diseases. They exhibit normal physiological functions and are free from symptoms that would indicate illness. Healthy participants are often used in clinical trials to establish baseline data or to test the effects of new treatments without the interference of existing health issues. Their inclusion helps researchers understand how a treatment or drug behaves in the absence of disease. These individuals typically have normal ranges in vital signs, laboratory tests, and physical examinations. They serve as a control group to compare against participants with specific medical conditions.

Trial ID:

2024-511301-31-00

Protocol code:

UP0152

Trial Phase:

Human Pharmacology (Phase I) – Other

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