Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Bioequivalence Study of Amoxicillin/Clavulanic Acid Oral Suspension Compared with Reference Product in Healthy Adult Volunteers under Fed Conditions

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial examines a medication that combines two antibiotics, Amoxicillin/Clavulanic acid, provided as a powder that is mixed with water to create a liquid oral suspension. The same antibiotic combination is also available as a branded product called Augmentin ES, which is prepared in the same way. The study enrolls adult men and women who are healthy and do not have an infection.

The purpose is to assess whether the test product and the branded product are bioequivalence, meaning they provide the same amount of medicine to the body. Participants will take one of the liquid preparations after a regular meal, then, after a short interval, will take the other preparation after another meal. Blood samples will be collected to compare how the two products are absorbed, without further technical detail.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    Arrive at the study site and read the information sheet that explains the purpose of the trial.

    Sign the consent form to confirm voluntary participation.

    Provide basic health information and undergo simple measurements such as weight and blood pressure.

    Receive instructions on how the study will be conducted, including the need to take medication with food.

  2. Step 2

    First dosing period

    Receive the first oral suspension, which contains amoxicillin 600 mg and clavulanic acid 42.9 mg (total dose 642.9 mg) in a 5 ml liquid form.

    Take the single dose by mouth after eating a standardized meal, following the fed condition requirement.

    A small amount of heparin solution (2.1 iu per ml) is administered intravenously as background medication during the visit.

  3. Step 3

    Monitoring after first dose

    Remain at the study site for a period of observation to allow the research team to check for any immediate side effects.

    Optional blood samples may be taken to assess how the medication is processed in the body, but no specific schedule is provided.

  4. Step 4

    Washout period

    A washout period is observed between the two dosing periods, during which no study medication is taken.

    The length of this period follows the crossover design of the trial.

  5. Step 5

    Second dosing period

    Receive the second oral suspension, which is the comparator product containing the same amounts of amoxicillin and clavulanic acid (642.9 mg total) in a 5 ml liquid form.

    Take the single dose by mouth after eating the same type of standardized meal.

    The same intravenous heparin solution (2.1 iu per ml) is administered as background medication.

  6. Step 6

    Final monitoring and study completion

    Stay for observation after the second dose to allow the team to record any side effects.

    Complete any final assessments required by the study protocol.

    Receive a summary of participation and any necessary follow‑up instructions.

Who can join the trial?

8 criteria

  • Be a healthy adult male or a female who is non‑pregnant and non‑breastfeeding, aged between 18 and 60 years, weighs more than 50 kg, and is of Caucasian race.
  • Do not currently smoke; if you used to smoke, you must have stopped at least 6 months before the first dose.
  • Have a Body Mass Index (BMI) between 18.5 and 30.0 kg/m² (BMI is a number that compares your weight to your height).
  • Be able to stay in the study for the whole period and sign a written informed consent form agreeing to take part.
  • Be in good overall health as shown by medical history, a physical exam, normal vital signs (heart rate, blood pressure, and body temperature), and a normal 12‑lead ECG (a test that records the heart’s electrical activity). Small variations that are not important to health are allowed.
  • Have all laboratory test results (blood work, urine, etc.) within the normal range or considered not important by the doctor.
  • Agree to use a highly effective method of birth control during the whole study if you are a female who could become pregnant, and for male participants as well.
  • Be able to speak and understand Czech fluently.

Who cannot join the trial?

34 criteria

  • Having any acute or chronic disease or health problem that could affect the safety of the study drug, how the body handles the drug, or the test results.
  • Having existing stomach, kidney, or liver diseases that could interfere with drug absorption, safety, or how the body processes the drug.
  • Having a serious illness that could change how the drug is absorbed, distributed, metabolized, or eliminated.
  • Having a severe allergy to the study drug, similar medicines, or any ingredients in the tablets.
  • Being seriously ill or having had major surgery within the past 28 days.
  • Having a serious mental illness or being unable to cooperate with the study staff.
  • Having a history of feeling faint when standing up (orthostatic hypotension) or showing this during screening.
  • Abusing drugs, alcohol (more than 40 g per day for men or 20 g per day for women), solvents, or caffeine.
  • Using any medication that can damage major organs (organ‑toxic drugs) within the last 90 days.
  • Using any systemic drugs that are known to change liver enzyme activity (hepatic metabolism) within the past 90 days.
  • Taking any prescription medicine (except stable hormonal birth control or hormone therapy) within 28 days before the first dose.
  • Taking any over‑the‑counter medicines, vitamins, herbal products, or food supplements within 14 days before the first dose.
  • Donating at least 500 mL of blood within 90 days, or donating plasma or platelets within 14 days before the first dose.
  • Getting a tattoo, body piercing, or any skin‑penetrating cosmetic treatment within 90 days unless the doctor says it does not matter.
  • Testing positive for illegal drugs in urine at screening or check‑in.
  • Testing positive for alcohol on a breath test at screening or check‑in.
  • Testing positive for nicotine (cotinine) in urine at screening.
  • Having a body temperature higher than 36.9 °C (98.4 °F) at screening or check‑in.
  • Having blood pressure outside the normal range (systolic 90‑140 mmHg or diastolic 60‑90 mmHg) after resting for 5 minutes, or a heart rate outside 50‑100 beats per minute during screening.
  • Having any major abnormal lab result, including a positive test for hepatitis B, hepatitis C, or HIV.
  • Having anemia (low hemoglobin) – less than 120 g/L for women or 130 g/L for men.
  • Having a positive pregnancy test, being breast‑feeding, or not having a recent pregnancy test result.
  • Having veins in the arms that are too small or difficult for blood collection.
  • Having less than 30 days between finishing another study and starting this one.
  • Having current or past atopic eczema (a type of skin allergy).
  • Having a known inability to absorb glucose and galactose (glucose‑galactose malabsorption).
  • Having an estimated kidney filtration rate (GFR) below 1 mL/s.
  • Having a history of jaundice or liver problems caused by the antibiotic Augmentin.
  • Having an active infection with mononucleosis (“mono”).
  • Having a severe allergic reaction in the past to penicillins, cephalosporins, or other beta‑lactam antibiotics.
  • Having phenylketonuria (PKU) or being allergic to the sweetener aspartame.
  • Having been vaccinated against COVID‑19 less than 14 days before screening or planning to receive a COVID‑19 vaccine during the study.
  • Having been hospitalized because of COVID‑19.
  • Testing positive for COVID‑19 by PCR or antigen test when required for safety before entering the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Amoxicillin/clavulanic acid oral suspension

    is the medication being tested in the study. It contains two antibiotics that work together: amoxicillin, which kills bacteria, and clavulanic acid, which helps amoxicillin work better by blocking a bacterial defense. Participants take this liquid form by mouth, and the study looks at how the body absorbs it compared to a standard product.

  • Heparin injection solution

    is given to participants as a background therapy. Heparin is an anticoagulant, which means it helps prevent blood clots. In the trial, it is administered through an IV line to ensure participants’ blood does not clot during the study procedures, providing a safe environment for the testing.

  • Augmentin ES oral suspension

    is the reference medication used for comparison. Like the test product, it contains amoxicillin and clavulanic acid in a liquid form that is taken by mouth. This well‑known brand serves as the standard against which the new formulation is measured to see if they behave the same way in the body.

What is already known about the treatment

  • Amoxicillin/Clavulanic acid

    This medication is given as an oral suspension that is swallowed, usually mixed with water. It is a well‑known antibiotic that is used to treat a wide range of bacterial infections such as ear, sinus, and lung infections. The drug works by two actions: amoxicillin blocks the building of the bacterial cell wall, while clavulanic acid stops enzymes that would destroy amoxicillin, making the combination more effective. It belongs to the class of beta‑lactam antibiotics combined with a beta‑lactamase inhibitor and has been extensively studied in medical literature.

  • Heparin sodium

    Heparin sodium is supplied as a clear solution for injection and is administered directly into a vein (intravenous). It is an established anticoagulant used to prevent or treat blood clots during surgery, dialysis, or other medical procedures. The drug works by binding to antithrombin, which then disables several clotting proteins, slowing down the clotting process. It is classified as an unfractionated heparin anticoagulant and has a long history of safety and efficacy data in medical research.

  • Augmentin ES

    Augmentin ES is provided as a powder that is reconstituted into an oral suspension and taken by mouth. It is the brand version of amoxicillin/clavulanic acid and is used to treat common bacterial infections such as bronchitis, urinary tract infections, and skin infections. Like the test product, it combines amoxicillin, which stops bacteria from forming their protective wall, with clavulanic acid, which blocks enzymes that would otherwise destroy amoxicillin. It is classified as a beta‑lactam antibiotic with a beta‑lactamase inhibitor and is widely documented in clinical studies.

Investigated diseases

Conditions this trial is registered against

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503233-22-00Protocol code01-AMO-CLA-BIO-22Estimated enrolment56 patientsSponsorTarchominskie Zaklady Farmaceutyczne Polfa S.A.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.