Study on How Pantoprazole Affects the Absorption of Mycophenolate Mofetil in Post-Transplant Patients

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What is this study about?

This clinical trial is focused on studying the effects of certain medications in patients who have undergone organ transplants. The study involves two main medications: Pantoprazole and Mycophenolate Mofetil. Pantoprazole is a type of medication known as a proton pump inhibitor, which helps reduce stomach acid. Mycophenolate Mofetil is used to prevent the body from rejecting a transplanted organ. The purpose of the study is to understand how taking Pantoprazole alongside Mycophenolate Mofetil affects the absorption of Mycophenolate Mofetil in the body.

Participants in the study will be given different formulations of Mycophenolate Mofetil, including both generic and brand-name versions, to see if there are any differences in how the body absorbs them when taken with Pantoprazole. The study will compare these formulations to determine if they are bio-equivalent, meaning they work in the same way and provide the same benefits. The study will last for a short period, with participants taking the medications orally, which means by mouth.

The trial aims to provide valuable information on how these medications interact, which could help improve treatment for transplant patients. By understanding the influence of Pantoprazole on Mycophenolate Mofetil, healthcare providers can make better-informed decisions about medication management in post-transplant care. The study is expected to conclude by the end of 2025.

1 initial visit

Upon joining the study, an initial visit is conducted. During this visit, eligibility is confirmed based on age, weight, and health status. A physical examination and laboratory tests are performed to ensure all criteria are met.

Informed consent is obtained, ensuring understanding of the study’s nature, objectives, and potential risks.

2 medication administration

The study involves taking two types of medications: pantoprazole and mycophenolate mofetil. Both medications are taken orally in tablet form.

Pantoprazole is administered as a 40 mg gastro-resistant tablet. The dosage and frequency are determined by the study protocol.

Mycophenolate mofetil is administered as a 500 mg film-coated tablet. The dosage and frequency are determined by the study protocol.

3 monitoring and follow-up

Regular monitoring is conducted to assess the absorption of the medications. This includes measuring the concentration of the medication in the blood over time.

The primary focus is on the maximum concentration and the area under the concentration-time curve, which helps in understanding how the body absorbs the medication.

4 completion of study

The study is estimated to conclude by November 28, 2025. Upon completion, a final assessment is conducted to ensure the participant’s health and to gather final data.

Participants are informed of the study’s outcomes and any relevant findings that may impact their health.

Who Can Join the Study?

Must be a healthy male volunteer as determined by medical history, lab tests, and physical examination.
Must be between 18 and 55 years old.
Must have a body weight over 50 kg and a Body Mass Index (BMI) between 18.5 and 30 kg/m². BMI is a measure of body fat based on height and weight.
Must have normal vital signs:
- Systolic blood pressure (the top number) between 90 and 149 mmHg.
- Diastolic blood pressure (the bottom number) between 50 and 89 mmHg.
- Heart rate between 50 and 90 beats per minute, measured after resting for 5 minutes while sitting.
Must have normal lab test results for blood and urine, or any deviations must be considered not significant by the study doctor.
Must be able to understand the study, including its purpose, risks, and side effects.
Must provide written informed consent, which means agreeing to participate after understanding the study details.

Who Cannot Join the Study?

Patients who are not post-transplantation recipients. This means the study is only for those who have had an organ transplant.
Females cannot participate. The study is only for male participants.
Individuals under the age of 18 or over the age of 65 cannot participate. The study is for adults between 18 and 65 years old.
People who are part of a vulnerable population cannot participate. This refers to groups who may need special protection, such as those with limited decision-making capacity.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Luieb Uxcyxpoukthr Mvgxpik Cehesma (wmixo	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	02.12.2024

Trial locations

Investigated drugs:

Proton Pump Inhibitors (PPI) are medications that help reduce the amount of acid produced in the stomach. They are often used to treat conditions like acid reflux or heartburn. In this clinical trial, PPIs are being studied to see how they affect the absorption of another medication, Mycophenolate mofetil. The goal is to understand if taking PPIs changes how well Mycophenolate mofetil works in the body.

Mycophenolate Mofetil (MMF) is a medication used to prevent the body from rejecting a transplanted organ, such as a kidney. It works by suppressing the immune system to stop it from attacking the new organ. In this trial, researchers are looking at how Mycophenolate mofetil is absorbed in the body when taken with PPIs. They are also comparing the original version of Mycophenolate mofetil with generic versions to see if they work the same way when taken with PPIs.

Investigated diseases:

Post-Transplantation State – This condition occurs after a person has received an organ or tissue transplant. The body may recognize the new organ as foreign, which can lead to an immune response. Over time, the immune system may attack the transplanted organ, a process known as rejection. To prevent this, patients often require medications to suppress the immune system. The condition involves ongoing monitoring to ensure the transplanted organ functions properly. The progression can vary depending on the type of organ transplanted and the individual’s response to treatment.

Trial ID:

2024-517043-32-00

Protocol code:

2024-517043-32-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on How Pantoprazole Affects the Absorption of Mycophenolate Mofetil in Post-Transplant Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?