Bioequivalence Study of Linagliptin 5 mg Film‑Coated Tablets in Healthy Volunteers for Diabetes Treatment

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What is this study about?

Diabetes is a condition in which the body has difficulty controlling blood sugar levels. The medication being studied is a 5 mg film‑coated tablet that contains linagliptin, a drug that helps lower blood sugar. The trial compares a test version of the tablet (Linagliptina) with an already marketed version (Trajenta), both taken by mouth.

The purpose of the study is to determine whether the test tablet delivers the same amount of drug to the body as the marketed tablet, showing that the two products are equivalent in their performance. In simple terms, “bioavailability” refers to how much of the medicine reaches the bloodstream, and “bioequivalence” means the two tablets behave the same way in the body.

Healthy volunteers receive a single dose of one tablet after an overnight fast, and blood samples are collected over several hours to measure drug levels. After a short break, the same participants receive the other tablet under the same conditions, and the process is repeated. This crossover design allows a direct comparison of the two formulations with only a brief participation period.

1 initial visit and consent

you attend the first study visit where the purpose of the trial is explained and you provide written consent to participate.

baseline measurements such as weight and vital signs are recorded.

2 fasting before the first dose

you are instructed to fast overnight, meaning no food or drink except water for at least 10 hours before the dosing day.

3 first single dose administration

under fasting conditions you swallow one linagliptin tablet containing 5 mg of the active substance.

the tablet may be the test formulation (linagliptina 5 mg coated tablet) or the comparator (trajenta 5 mg film‑coated tablet), depending on the random assignment.

4 post‑dose fasting period

after taking the tablet you continue to avoid food and drink (except water) for the period specified by the study staff.

5 washout period

a washout interval is observed to allow the drug to be cleared from your body before the next dosing session.

the length of this interval follows the study protocol.

6 fasting before the second dose

you again fast overnight, following the same instructions as before the first dose.

7 second single dose administration (crossover)

under fasting conditions you swallow one linagliptin tablet containing 5 mg of the active substance.

this time you receive the formulation that was not taken during the first dosing session, completing the crossover design.

8 final monitoring and study completion

after the second dose you follow any remaining instructions from the study team, such as final fasting or observation periods.

the study concludes once all required assessments are completed.

Who Can Join the Study?

Agree to take part by signing a written consent form after being told about the study, its goals, possible risks, and that they can stop at any time.
Be between 18 and 55 years old.
Have no important physical (organic) or mental (psychic) health problems.
Have normal results in their medical records and in a physical exam performed by the study doctors.
Show normal blood test results, including haematology (blood cell counts), coagulation (blood clotting), biochemistry (blood chemistry), and serology (tests for infections such as Ag HBs for hepatitis B, HC antibodies for hepatitis C, and HIV antibodies), and also have normal urine test (urinalysis).
Have normal vital signs (blood pressure, heart rate, temperature, breathing rate) and a normal heart rhythm test called an electrocardiogram.

Who Cannot Join the Study?

Having a physical (organic) or mental (psychic) illness, especially if lab tests show significant kidney or liver problems such as enzyme levels (GOT, GPT, GGT) more than 2.5 times the normal limit or total bilirubin more than 1.5 times normal (bilirubin is a substance processed by the liver).
Participating in another clinical study that used experimental drugs within the past 3 months (or at least 1 month/5 half‑lives if the drug was already marketed).
Being unable to follow the study instructions or cooperate during the trial.
Having difficulty swallowing.
Taking any prescription medication in the last 15 days, or any medication in the 48 hours before receiving the study drug (women may use contraceptives, but they must have started them at least 4 weeks before the study and keep the same method throughout).
Having a body mass index (BMI) outside the range of 18.5–30.0 (BMI is calculated as weight in kilograms divided by height in meters squared).
Having a known allergy or sensitivity to any medication.
Testing positive on a drug screen for cannabis, opiates, cocaine, or amphetamines.
Being a regular smoker.
Drinking alcohol daily or having experienced acute alcohol poisoning in the past week.
Having donated blood within the month before the study starts.
Being pregnant or breastfeeding, or being a woman of child‑bearing age who cannot commit to using a highly effective birth‑control method or abstaining during the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hmclfrjk Usuzgqjtxnhfh Dj Lw Pigqxcot	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	03.07.2023

Trial locations

Investigated Drugs:

Linagliptin

Trajenta is a tablet that contains the medicine linagliptin. In this study it is used as the reference product, meaning it is the standard drug that is already approved and available on the market. The trial compares the test tablet to this reference to see if they work the same way in the body.

Linagliptina is a tablet that also contains linagliptin, but it is the new formulation being tested. The study gives healthy volunteers this tablet and then measures how much of the drug gets into their blood. The goal is to show that this new tablet behaves the same as the reference tablet, Trajenta.

Investigated Diseases:

Diabetes mellitus

Diabetes mellitus – Diabetes mellitus is a long‑term condition in which the body has difficulty controlling blood sugar levels. It occurs when the pancreas does not make enough insulin or the body’s cells do not respond properly to the insulin that is produced. As a result, glucose builds up in the bloodstream. Over time, the elevated sugar can affect how the body uses energy. The disease usually starts with mild increases in blood sugar and can progress to consistently high levels if not managed.

Trial ID:

2023-506047-41-00

Protocol code:

UECHUP-LIN/23-3

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Bioequivalence Study of Linagliptin 5 mg Film‑Coated Tablets in Healthy Volunteers for Diabetes Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?