Study on the Bioequivalence of Pregabalin 300 mg Tablets and Capsules in Healthy Volunteers

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What is this study about?

This clinical trial is focused on studying the medication Pregabalin, which is commonly used to treat conditions like nerve pain, epilepsy, and anxiety disorders. In this study, two different forms of Pregabalin are being compared: a 300 mg tablet called Pregabalina Normon and a 300 mg hard capsule known as Lyrica. The trial involves healthy volunteers who will receive a single dose of each formulation to see how the body absorbs the medication.

The purpose of the study is to evaluate the relative bioavailability, which means understanding how much of the drug enters the bloodstream and how quickly it does so. This will help determine if the two forms of Pregabalin are bioequivalent, meaning they work in the same way and provide the same benefits. Participants will take the medication under fasting conditions, which means they will not eat before taking the dose, to ensure consistent results.

Throughout the study, participants will be monitored to ensure their safety and to collect data on how the medication is processed by the body. The trial is designed to provide valuable information about the effectiveness and safety of these two formulations of Pregabalin, contributing to better treatment options for patients in the future.

1 joining the study

Upon joining the study, participants are required to provide written consent after being informed about the study’s design, objectives, and potential risks. Participation is voluntary, and consent can be withdrawn at any time.

2 initial health assessment

Participants undergo a health assessment to ensure they meet the study’s inclusion criteria. This includes a review of medical history, a physical examination, and laboratory tests to check blood and urine samples. Vital signs and an electrocardiogram are also performed to ensure no significant health issues are present.

3 first medication administration

Participants receive a single oral dose of pregabalin 300 mg in the form of either a hard capsule or a tablet. This is done under fasting conditions, meaning no food is consumed for a specified period before taking the medication.

4 monitoring and data collection

After taking the medication, participants are monitored for a period to collect data on how the body absorbs and processes the drug. This involves measuring the concentration of the drug in the blood at various times to determine the bioavailability of the medication.

5 crossover and second medication administration

In a crossover design, participants will later receive the alternative formulation of pregabalin (either the capsule or the tablet, depending on what was initially received). This allows for comparison between the two formulations.

6 final monitoring and data collection

Similar to the first administration, participants are monitored after taking the second formulation. Data is collected to compare the bioequivalence of the two formulations, ensuring they have similar effects in the body.

7 completion of the study

Upon completion of all required steps, participants may undergo a final health assessment to ensure no adverse effects have occurred. The study concludes with the collection of all data for analysis.

Who Can Join the Study?

Participants must be healthy volunteers, meaning they should not have any significant health issues.
Participants can be male or female.
Participants must be between the ages of 18 to 55.
Participants must provide written consent after being informed about the study, its goals, and any potential risks.
Participants should not have any clinically significant (important) physical or mental health conditions.
Participants should not have any important abnormalities in their medical records or during a physical examination.
Participants should not have any important abnormalities in their blood tests, which include tests for blood cells, blood clotting, blood chemistry, and tests for infections like hepatitis and HIV.
Participants should not have any important abnormalities in their vital signs (such as blood pressure and heart rate) or in their electrocardiogram (ECG), which is a test that checks the heart’s electrical activity.

Who Cannot Join the Study?

Participants must be healthy volunteers. This means you should not have any ongoing medical conditions.
Participants must be within a specific age range. Please ensure you meet the age requirements for the study.
Both men and women can participate in the study.
Participants should not be part of a vulnerable population. This includes groups that may need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hduhzkin Ukrycjdprlfqr Dh Lu Pwyzejdo	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	12.09.2022

Trial locations

Investigated drugs:

Pregabalin

Pregabalin is a medication used in this clinical trial to compare two different forms: tablets and hard capsules. The purpose of the trial is to see if the body absorbs both forms in the same way when taken by healthy volunteers who have not eaten. Pregabalin is often used to treat nerve pain, seizures, and anxiety. In this study, researchers want to make sure that the new tablet form works just as well as the capsule form that is already available. This helps ensure that patients can expect the same effects and safety from both forms of the medication.

Healthy volunteers – This term refers to individuals who do not have any known significant health conditions or diseases. They are typically used in clinical trials to establish baseline data or to test new treatments or medications. Healthy volunteers are expected to have normal physiological functions and are free from any chronic or acute illnesses. Their participation helps researchers understand how a drug or treatment behaves in a body without the influence of existing health issues. The progression of their health status is generally stable, as they do not have underlying conditions that could alter the study’s outcomes.

Trial ID:

2022-501160-18-00

Protocol code:

N-PRE-22-273

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Study on the Bioequivalence of Pregabalin 300 mg Tablets and Capsules in Healthy Volunteers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?