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Bioavailability of ibuprofen 2% and 4% oral suspensions compared with standard ibuprofen oral suspension in healthy adult males and females

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What is this trial about?

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

The trial involves healthy adult volunteers and does not focus on any specific disease. The medication being examined is ibuprofen given as an oral suspension. Two new formulations containing 2 % (20 mg/mL) and 4 % (40 mg/mL) ibuprofen are compared with the reference product Nurofen 40 mg/mL oral suspension.

The aim of the study is to determine whether the two new suspensions are bioequivalent to the reference, meaning they deliver the same amount of medicine to the bloodstream and work in the same way.

Participants will receive a single dose of each of the three suspensions on separate occasions while fasting (no food in the stomach). After each dose, blood samples will be taken at several time points to see how much ibuprofen reaches the blood and how quickly it is cleared. The order in which the suspensions are taken is randomly assigned, and the study is open‑label, so both investigators and participants know which product is being used.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Consent

    You receive information about the study and sign a consent form indicating that you agree to take part.

    The study staff confirms that you are a healthy adult without any medical conditions that would affect the trial.

  2. Step 2

    Randomization to Treatment Sequence

    The study team assigns you to one of six possible orders in which you will receive the three oral suspensions.

    Each order includes the reference product (Nurofen®) and two test products containing ibuprofen at 2% and 4% concentrations.

  3. Step 3

    First Study Visit – First Dose

    You arrive at the clinic after fasting for at least ten hours (no food or drink except water).

    A single oral dose of 400 mg ibuprofen is given as a measured amount of the assigned suspension.

    The dose is taken under observation; for the reference product you will drink 10 ml, for the 2% suspension you will drink 20 ml, and for the 4% suspension you will drink 10 ml.

    After the dose, a series of small blood samples are taken at specific times to measure how much ibuprofen is in your bloodstream.

    You remain in the clinic for the required sampling period and are monitored for any adverse reactions.

  4. Step 4

    Washout Period

    You do not take any study medication for several days (the washout period) to allow the previous dose of ibuprofen to leave your body completely.

    During this time you may resume normal eating and drinking habits.

  5. Step 5

    Second Study Visit – Second Dose

    You fast again for at least ten hours before arriving at the clinic.

    A single oral dose of 400 mg ibuprofen is administered using the second suspension assigned by your randomization sequence.

    The same procedure of supervised dosing and timed blood samples is followed as during the first visit.

  6. Step 6

    Second Washout Period

    You refrain from taking any study medication for another washout period to clear the second dose of ibuprofen from your system.

  7. Step 7

    Third Study Visit – Third Dose

    You fast for at least ten hours before the final clinic visit.

    A single oral dose of 400 mg ibuprofen is given using the third suspension in your sequence.

    The same supervised dosing and series of blood samples are performed.

  8. Step 8

    Study Completion and Final Assessment

    After the last blood sampling, the study staff reviews the collected data and confirms that all required procedures are finished.

    You receive a summary of your participation and any final instructions, concluding your involvement in the trial.

Who can join the trial?

8 criteria

  • Be able to understand and sign the informed consent form, which shows you agree to follow the study rules.
  • Be a healthy man or woman between 18 and 45 years old when you sign the consent.
  • Be judged healthy by the study doctor based on normal medical exams, lab tests, and other routine checks.
  • Weigh at least 50 kg and have a Body Mass Index (BMI) between 18.5 and 30 kg/m² (BMI is a measurement that compares your weight to your height).
  • Not smoke any tobacco for at least 3 months before screening, confirmed by a cotinine test (a lab test that detects tobacco use).
  • If you are a woman who could become pregnant, have a negative urine pregnancy test (a quick test that checks for pregnancy) within 24 hours before the first dose.
  • Women who are postmenopausal (no menstrual periods for at least 1 year) or surgically sterile (have had tubal ligation, removal of ovaries, or removal of the uterus) do not need the pregnancy test.
  • Women who can become pregnancy must agree to use a reliable form of contraception (birth control) with a success rate over 90%—such as condoms with spermicide, hormonal pills, injections, patches, implants, vaginal rings, intra‑uterine devices, or agree to abstain from sexual activity—throughout the study and for 15 days after the last dose.

Who cannot join the trial?

29 criteria

  • If you have any past or current allergies, you cannot join the study.
  • If your recent blood tests (blood count, chemistry or urine tests) show results that are far from normal, you are not eligible.
  • If your blood pressure while lying down is lower than 100 mmHg or higher than 130 mmHg for the top number, or lower than 60 mmHg or higher than 89 mmHg for the bottom number, you cannot participate.
  • If your heart beats slower than 60 or faster than 100 times per minute, you are excluded.
  • If you are a woman who is trying to become pregnant, currently pregnant, or breastfeeding, you cannot take part.
  • If a screening test shows you have HIV, hepatitis B (HBsAg or anti‑HBc), hepatitis C (anti‑HCV) or syphilis, you are not eligible.
  • If a screening test shows any illegal drugs or recent alcohol use, you cannot join.
  • If a urine test shows cotinine (a marker of recent tobacco use), you are excluded.
  • If the investigator believes you have a history or suspicion of drug or alcohol abuse, you cannot participate.
  • If you have drunk more than 10 units of alcohol per week (one unit equals a glass of wine, a small spirit, or half a pint of beer) within the last six months, you are not eligible.
  • If you have consumed coffee, tea, chocolate, cacao, energy drinks, cola, citrus fruits or cranberry products (including juices) within 24 hours before the first dose, you cannot join.
  • If you are known to be allergic or intolerant to ibuprofen, other NSAIDs (non‑steroidal anti‑inflammatory drugs), fructose, or any ingredient of the study medication, you are excluded.
  • If you have taken medicines that affect heart function, blood pressure, liver, or similar systems (such as barbiturates, omeprazole, cimetidine, other NSAIDs, ACE inhibitors, ARBs, diuretics) within the last two months, you cannot participate.
  • If you have used any prescription or over‑the‑counter medicines, herbal remedies, vitamins or minerals within the last two weeks (or longer if the drug stays in the body a long time), you are not eligible.
  • If you have mental, physical or other issues that, in the investigator’s opinion, would prevent you from following the study rules or understanding the risks, you cannot join.
  • If you have been dehydrated (for example because of diarrhea or vomiting) within the past 48 hours, you are excluded.
  • If you have followed a special diet such as a vegetarian or a very low‑calorie diet (< 1000 kcal per day) within the last 28 days, you cannot participate.
  • If you donated plasma within one month or gave more than 500 mL of blood within the last three months, you are not eligible.
  • If you are unwilling or unable to follow the study procedures and restrictions, you cannot join.
  • If you have taken part in another clinical study within the past three months, you are excluded.
  • If you are a woman of child‑bearing potential who has had unprotected sex with a man who is not sterilized (no vasectomy) within the last 30 days, you cannot participate.
  • If the investigator believes any other reason would prevent you from safely taking part, you are not eligible.
  • If you have had bronchospasm, asthma, rhinitis, angioedema or hives after taking aspirin or other NSAIDs, you are excluded.
  • If you have a serious heart, lung, liver, kidney, blood, stomach, hormone, immune, infection, skin, nerve or mental health condition, you cannot join.
  • If you have had two or more stomach ulcers or episodes of gastrointestinal bleeding, or bleeding related to previous NSAID use, you are not eligible.
  • If you have active bleeding in the brain or elsewhere, you are excluded.
  • If you have had an acute infection such as flu, COVID‑19 or another respiratory infection within the past four weeks, you cannot participate.
  • If you have any other important disease or disorder that the investigator thinks could put you at risk or affect the study results, you are not eligible.
  • If you have had major abdominal surgery or any abdominal surgery within the past three months, you are excluded.
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Investigated drugs

  • Nurofen children orange oral suspension

    is a liquid medicine that contains ibuprofen, a common pain reliever and fever reducer. In this study it is used as the reference product, meaning it serves as the standard against which the new test formulations are compared. Participants take this familiar suspension to see how the new versions perform in terms of how much of the drug gets into the bloodstream.

  • Test ibuprofen oral suspension (low concentration)

    is a newly reformulated liquid form of ibuprofen that contains a lower amount of the active ingredient compared with the high‑concentration version. It is given to participants to evaluate how well the drug is absorbed when taken on an empty stomach. The goal is to determine if this low‑strength formulation works the same way as the standard Nurofen product.

  • Test ibuprofen oral suspension (high concentration)

    is another newly reformulated liquid form of ibuprofen, but it contains a higher amount of the active ingredient than the low‑concentration version. Like the other test product, it is taken by participants in a fasted state so researchers can compare its absorption and overall performance to the reference Nurofen suspension. The study aims to see if this higher‑strength formulation is bioequivalent to the standard product.

What is already known about the treatment

  • Nurofen dla dzieci Forte pomarańczowy, 40 mg/ml, zawiesina doustna

    This is an oral suspension that is taken by mouth, usually using a measuring spoon. It is an over‑the‑counter medication that is widely approved and used for relieving pain and fever in children. The drug works by blocking enzymes called COX, which reduces substances that cause pain and inflammation. It belongs to the class of non‑steroidal anti‑inflammatory drugs (NSAIDs).

  • Ibuprofen 2% oral suspension

    This product is a liquid suspension taken orally with a dose spoon. It is a newly reformulated version of ibuprofen that is being studied for its bioavailability, but it contains the same active ingredient that is already approved for pain and fever relief. It reduces pain and inflammation by inhibiting COX enzymes, lowering the body’s production of prostaglandins. Like the reference product, it is classified as a non‑steroidal anti‑inflammatory drug (NSAID).

  • Ibuprofen 4% oral suspension

    This is also an oral liquid suspension administered with a measuring device. It is another reformulated ibuprofen preparation under investigation, containing a higher concentration of the same active drug used for pain and fever control. The medication acts by blocking COX enzymes, which decreases the chemicals that cause inflammation and pain. It is placed in the non‑steroidal anti‑inflammatory drug (NSAID) category.

Trial detailsLast updated 18 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503703-28-00Protocol codeBCLT/22/IBU-BE/001Estimated enrolment75 patientsSponsorBerlin-Chemie AG

sourced from the EU Clinical Trials Register and site verification

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