Single‑dose Bioavailability of Gliclazide Modified‑Release Tablets in Healthy Volunteers (Type 2 Diabetes)

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What is this study about?

The study focuses on Type 2 diabetes mellitus, a condition in which the body does not use insulin properly, leading to high blood sugar. The medication being examined is gliclazide, an oral drug that helps lower blood sugar, and a brand‑name version called Diamicron. Both are available as modified release tablets, which are designed to release the medicine slowly over time, and as an oral solution. The research compares tablets that release the drug at fast, medium, or slow rates, and also looks at how the drug behaves when taken on an empty stomach (fasting) versus after a meal (fed).

The purpose of the study is to assess the bioavailability and pharmacokinetics of the different tablet formulations, meaning how much of the drug reaches the bloodstream and how the body absorbs, distributes, and clears it. Healthy volunteers receive each formulation in a single dose, with a short break between doses, and blood samples are taken to measure drug levels. Safety is monitored through checks for side effects, routine lab tests, vital signs, and a simple heart‑electric test (ECG).

1 enrollment and baseline assessments

after signing the consent form, basic health measurements such as blood pressure, heart rate, and laboratory tests are recorded.

these baseline values will be used later to compare the effects of the study medicines.

2 fasting before each dose

you will be asked not to eat or drink anything except water for at least ten hours before taking a study medicine.

this ensures that food does not affect how the medicine is absorbed.

3 first single dose (fasting condition)

you will swallow one gliclazide modified‑release tablet containing 120 mg of the active ingredient.

the tablet may have a fast, medium, or slow release rate depending on the study period.

after taking the tablet you will remain in the clinic for a series of blood draws that may continue for up to 24 hours to measure drug levels.

4 monitoring for low blood sugar

if your blood sugar drops too low, a small amount of intravenous glucose (5 g) can be given through a vein to raise it.

the same safety checks are performed after every dose.

5 washout period

after the first dose, you will wait at least seven days before receiving the next study medicine.

this gap allows the previous dose to leave your body completely.

6 second single dose (fasting condition, different formulation)

you will receive another single dose under the same fasting rules.

the dose may be a different gliclazide tablet (fast, medium, or slow release), the comparator tablet diamicron 60 mg (which also contains gliclazide), or a 60 mg gliclazide oral solution.

the same monitoring and blood‑sampling schedule is followed.

7 fed condition preparation

for the fed part of the study you will eat a standardized high‑fat meal.

the meal is given exactly one hour before you take the study tablet.

8 single dose under fed condition

you will swallow one 120 mg gliclazide modified‑release tablet with a medium release rate.

after the meal and the tablet, blood samples are taken over several hours to see how food influences drug absorption.

the same safety monitoring, including possible intravenous glucose, is provided.

9 final assessments and study completion

after the last dose and the required washout period, final health checks are performed.

once all measurements are completed, the study is considered finished for you.

Who Can Join the Study?

Provide a free written informed consent before any study procedures are done.
Have a negative blood test (serology) for HIV, Hepatitis B (both surface antigen and core antibody), and Hepatitis C antibodies, meaning no current infection.
Be a non‑smoker or an ex‑smoker who has not used tobacco or nicotine products for at least three months before screening.
If you are a woman, either be unable to become pregnant (non‑childbearing potential) or, if you can become pregnant, agree to use an approved birth‑control method (non‑hormonal or hormonal) for at least four weeks before the first dose and continue it for four weeks after the last dose.
If you are a man, be infertile, have had a successful vasectomy, or agree to follow contraception rules (either avoid heterosexual intercourse or use a barrier method such as a male condom) from the start of the study until four weeks after the last dose.
If you are a man, agree not to donate sperm during the study and for three months (90 days) after the last dose.
Be willing to follow all study procedures, any restrictions, and be available for the entire study period.
Be between 18 and 50 years old at the time you sign the consent.
Weigh at least 50 kg (about 110 lb) if male or at least 48 kg (about 106 lb) if female, and have a body mass index (BMI) between 18.5 and 30.0.
Have no significant medical problems in your history, as judged by the study doctor.
Have a normal physical exam, as judged by the study doctor.
Have normal vital signs (such as blood pressure and heart rate), as judged by the study doctor.
Have a normal 12‑lead ECG (a test that records the heart’s electrical activity), as judged by the study doctor.
Have normal results on all clinical laboratory tests (blood work, urine, etc.) within the lab’s normal range, or any abnormal results must be considered not clinically important by the study doctor.

Who Cannot Join the Study?

Allergy or known severe reaction to the study drug or any of its inactive ingredients (hypersensitivity).
Low blood hemoglobin (below 12.0 g/dL for women or 13.2 g/dL for men), which means the blood may not carry enough oxygen.
High liver enzymes (AST or ALT) above the normal range, indicating possible liver problems.
Poor kidney function measured by a low creatinine clearance (below the normal limit), meaning the kidneys may not filter waste well.
Positive test for illegal drugs, nicotine (cotinine), or alcohol.
Positive pregnancy test.
Use of a long‑acting (depot) injection or implant of any drug (except birth control) within the last 6 months.
Use of corticosteroids (steroid medicines) within the last 6 months.
Regular use of any prescription or over‑the‑counter medication in the past 30 days (except birth control).
Drinking more than 14 units of alcohol per week for men or more than 7 units per week for women in the past 6 months.
Drinking more than 5 servings of caffeinated beverages (coffee, tea, soda) each day.
Having galactose intolerance, total lactase deficiency (cannot digest lactose), or glucose‑galactose malabsorption.
Participation in another clinical trial in the past 2 months.
Participation in more than two clinical trials in the past 12 months.
Blood donation, loss of 450 mL or more of blood, or plasma exchange (plasmapheresis) in the past 3 months.
Difficulty fasting or having dietary restrictions (e.g., lactose intolerance, vegan, low‑fat, low‑sodium) that could interfere with study meals.
Difficulty swallowing capsules or tablets.
Poor veins in the forearm or hand that make it hard to place a peripheral IV line.
Currently breastfeeding (lactating).
Any other condition the investigator believes makes participation unsafe or unsuitable.
Recent illness, condition, or treatment that could increase risk or affect how the drug is measured in the body.
Use of any medication in the prior 30 days that the investigator thinks could change the drug’s behavior or the subject’s health status.
Severe allergy to any other medication.
Use of the antifungal drug miconazole in the past 30 days.
Eating pineapple, Seville oranges, pomelo, pomegranate, starfruit, or grapefruit (fresh, canned, or frozen) within the week before dosing or during washout periods.
Consuming any alcoholic beverage within 24 hours before dosing.
Medical conditions affecting the stomach, kidneys, liver, or pancreas (such as ulcers, inflammatory bowel disease, pancreatitis) or past surgeries (like gallbladder removal or stomach surgery) that could change how the drug is absorbed, distributed, metabolized, or excreted.
History of documented severe low blood sugar (hypoglycemia).
History of glucose‑6‑phosphate dehydrogenase (G6PD) deficiency, a blood enzyme disorder.
History of endocrine (hormone) diseases.
Major surgery within 30 days before the study drug or planned within 30 days after the last dose.
History of drug or alcohol abuse.

Where you can join this trial?

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Site Name	City	Country	Status
Blbrgiduovrq Ilfpzovjlipr E Degyndbbdjparhi El Sqpgs Losk	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	06.11.2023

Trial locations

Investigated Drugs:

Gliclazide oral solution
This is a liquid form of the diabetes medicine gliclazide that is taken by mouth. In the study it was given to healthy volunteers under fasting conditions to act as a reference product, allowing researchers to compare how the tablet forms of the drug are absorbed in the body.

Diamicron
Diamicron is a brand name for a modified‑release tablet that contains gliclazide. The tablet is designed to release the medicine slowly over time. In the trial it served as the standard comparator, so the new test tablets could be evaluated against an already approved formulation.

Gliclazide modified‑release tablet (Test A)
Test A is an experimental version of a gliclazide tablet that releases the drug at a controlled rate. The study included three versions of Test A – one that releases the medicine quickly, one with a medium speed, and one that releases it slowly. Each version was taken once to see how the different release speeds affect the amount of drug that reaches the bloodstream.

Gliclazide modified‑release tablet (Test B)
Test B is another experimental gliclazide tablet, also designed to release the drug in a controlled manner. Like Test A, it was made in three release‑rate versions – fast, medium, and slow. The purpose was to compare these new formulations with each other and with the standard Diamicron tablet under both fasting and fed conditions.

Glucose intravenous infusion
Glucose was given through a vein (IV) as a background therapy during the study. It provides a steady source of sugar in the blood, helping researchers monitor how the different gliclazide formulations affect blood sugar control while ensuring participants remain safe throughout the trial.

Investigated Diseases:

Type 2 diabetes mellitus

Type 2 diabetes mellitus – A chronic condition in which the body does not use insulin effectively, leading to elevated blood sugar levels. Over time the pancreas produces less insulin as the cells become increasingly stressed. This results in a gradual rise in glucose that can affect many organs. The disease often develops slowly, starting with mild increases in blood sugar that become more pronounced if left unmanaged.

Trial ID:

2023-507802-15-00

Protocol code:

S005190-170

Trial Phase:

Human Pharmacology (Phase I) – Other

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Single‑dose Bioavailability of Gliclazide Modified‑Release Tablets in Healthy Volunteers (Type 2 Diabetes)

What is this study about?

Who Can Join the Study?

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