A study to compare how the body absorbs empagliflozin tablets in healthy individuals.

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What is this study about?

This study aims to compare how much of a medication enters the bloodstream when using two different versions of the same drug. The research focuses on empagliflozin, which is provided in two forms: a test version and the brand-name version known as Jardiance. Both are administered as a 25 mg film-coated tablet, which is a pill covered in a thin layer to make it easier to swallow.

The study examines bioavailability, a term used to describe the rate and amount at which a drug is absorbed by the body and becomes available at the site of action. This research will be conducted in healthy individuals under fasting conditions, meaning participants will not eat before taking the medication. Participants will undergo a crossover process, where they receive both types of tablets at different times during the study to allow for a direct comparison between the two products.

Who Can Join the Study?

You must provide your free written informed consent, which means you agree to participate in the study after being fully informed about everything involved.
You must be willing to follow all the rules and procedures required by the study.
Women must either be unable to have children or, if they are able to have children, they must agree to use a reliable contraceptive method (a way to prevent pregnancy) from 4 weeks before the study starts until 2 weeks after it ends.
You must be a man or a woman between the ages of 18 and 55 years at the time you sign the agreement.
Your Body Mass Index (BMI), which is a measure used to determine if your weight is healthy for your height, must be between 18.5 and 30.0.
You must have no significant medical history of diseases that could affect the study.
Your physical examination, which is a routine check by a doctor, must show no significant health problems.
Your 12-lead ECG, a test that records the electrical activity of your heart, must show normal results.
Your laboratory tests, which are blood or urine tests, must show no significant abnormalities.
You must test negative for HIV (a virus that affects the immune system), Hepatitis B, and Hepatitis C (viruses that affect the liver).
You must be a non-smoker or someone who has not used tobacco or nicotine products for at least 3 months before the study begins.

Who Cannot Join the Study?

A known allergy or hypersensitivity (an extreme immune reaction) to the study medicine or any of its ingredients, such as lactose (a milk sugar) or titanium dioxide (a white pigment).
Low blood pressure, specifically a top number (systolic) below 90 or a bottom number (diastolic) below 45 when measured while sitting.
High levels of liver enzymes (specifically ALT or AST), which are proteins in the blood that can indicate liver health.
Low kidney function, measured by creatinine clearance (a calculation of how well the kidneys filter waste from the blood).
Testing positive for illegal drugs or alcohol.
Having received a long-acting injection or implant of any medicine (except birth control) in the last 6 months.
Drinking more than 14 units of alcohol per week for men, or more than 7 units for women, over the last 6 months.
Consuming more than 500 mg of methylxanthines (stimulants found in coffee, tea, or chocolate) every day.
Taking part in another medical study within the last 2 months.
Taking part in more than 2 medical studies within the last 12 months.
Donating blood, losing a large amount of blood (450 mL or more), or having plasmapheresis (a process to separate plasma from blood) in the last 2 months.
Having rare genetic issues with how the body processes sugars, such as galactose intolerance or lactase deficiency.
Having any dietary restrictions (such as being vegan or having a low-salt diet) or difficulty fasting (not eating for a set period) that might interfere with the study diet.
Having veins in either arm that are not suitable for a needle to be inserted.
Having difficulty swallowing tablets or capsules.
Being pregnant or currently breastfeeding.
Using any medicines, vitamins, or herbal supplements (like St John’s Wort) in the last 2 weeks, unless the doctor says it is safe.
Consuming products with xanthines (like energy drinks, coffee, or chocolate) within 48 hours before taking the study medicine.
Having a history of a severe allergic reaction to any other drug.
Eating pineapple, Seville oranges, pomelo, pomegranate, starfruit, or grapefruit within the last week.
Having any medical condition involving the stomach, kidneys, or liver (such as ulcers, inflammatory bowel disease, or pancreatitis) that could change how the body processes the medicine.
Having had surgery on the stomach or digestive tract (such as removing the gallbladder or part of the stomach).
A history of diabetes.
A history of heart disease.
A history of pancreatitis (inflammation of the pancreas).
A history of kidney or liver problems.
A history of orthostatic hypotension (a sudden drop in blood pressure when standing up), fainting, or syncope (the medical term for passing out).
Any other health condition that the doctor believes makes it unsafe or difficult for you to participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Bbnvhpmkqgkz Ijdnnlswprpj E Dneymhejmzlxgod Ee Szjsb Lgsz	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	23.08.2023

Trial locations

Investigated drugs:

Empagliflozin

Empagliflozin is a medication used to help manage blood sugar levels. In this study, it is being tested to see how well the body absorbs the medicine when taken as a tablet.

Jardiance is a medication used to help manage blood sugar levels. In this study, it is being used as a comparison to see how its absorption in the body compares to the test medication.

Based on the provided source data, no specific medical condition or disease is identified for description, as the “Medicalconditions” field states “No medical condition.”

Trial ID:

2023-506416-41-00

Protocol code:

BLCL-EMP-PIL01

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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A study to compare how the body absorbs empagliflozin tablets in healthy individuals.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?