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A study to compare how the body absorbs celecoxib oral suspension and celecoxib capsules in healthy adults for the treatment of acute pain.

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study is designed to compare how the body absorbs and uses two different forms of the medication celecoxib. The research focuses on conditions such as acute pain, which is sudden and short-term pain, as well as dysmenorrhea, commonly known as painful menstrual cramps, and various musculoskeletal and connective tissue disorders involving the muscles and joints. The investigation will compare a liquid version of the medication, known as celecoxib oral suspension, against the standard Celebrex capsules. Additionally, some participants may receive heparin, a medication typically used to prevent blood clots, as part of their background care.

The purpose of the study is to evaluate the bioavailability, which refers to the amount of a drug that enters the bloodstream and becomes available to produce an effect, and to see how eating food influences this process. During the trial, participants will receive a single dose of the medication under different conditions. This includes periods where they have not eaten, known as a fasted state, and periods after consuming a meal, known as a fed state. By comparing these different scenarios, researchers can determine if the liquid form works similarly to the capsule form and how food intake affects the medication's performance.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    First administration phase

    A single dose of celebrex (celecoxib) capsules, which is 200 mg, is taken by mouth.

    This step is performed under two different conditions: in a fasted state (without food) and in a fed state (after eating a meal).

  2. Step 2

    Second administration phase

    A single dose of celecoxib oral suspension, which is 20 ml (equivalent to 200 mg), is taken by mouth.

    This step is also performed under two different conditions: in a fasted state (without food) and in a fed state (after eating a meal).

  3. Step 3

    Blood sampling

    Blood samples are collected to measure how the medicines are absorbed and processed by the body.

Who can join the trial?

9 criteria

  • Participants must be healthy males or females who are not currently pregnant or breastfeeding.
  • Participants must be between 18 and 60 years of age on the day they agree to join the study.
  • Participants must be non-smokers or people who quit smoking at least 6 months before taking the first dose.
  • Participants must have a Body Mass Index (BMI), which is a measure of body fat based on height and weight, between 18.5 and 30.0 kg/m2.
  • Participants must be available for the entire duration of the study and provide written informed consent, which is a signed document agreeing to participate.
  • Participants must be in good health, confirmed through a review of medical history, a physical examination, checking vital signs (such as heart rate, blood pressure, and body temperature), and a 12-lead ECG, which is a test that records the electrical activity of the heart.
  • All laboratory screening results, such as blood or urine tests, must be within the normal range or considered not serious by the doctor.
  • Both male and female participants must agree to use highly effective contraception (methods to prevent pregnancy) during the study and for at least 30 days after the last dose.
  • Participants must speak and understand the Czech language fluently.

Who cannot join the trial?

31 criteria

  • Having current or past diseases related to the blood, stomach and intestines, heart, kidneys, or liver that could change how the body processes the study drug.
  • A positive cotinine test, which measures how much nicotine (a substance found in tobacco) is in your urine.
  • Being pregnant, breastfeeding, or having a positive pregnancy test.
  • Abuse of drugs, alcohol (more than 40 grams per day for men or 20 grams per day for women), solvents (chemicals that can be inhaled), or caffeine.
  • Having a serious mental illness or being unable to work with the medical team.
  • Having blood pressure (the force of blood against artery walls) or heart rate (how many times your heart beats per minute) outside of the allowed healthy ranges after resting.
  • Having orthostatic hypotension, which is a sudden drop in blood pressure when you stand up.
  • Having a body temperature that is consistently outside the normal range of 35.4 to 36.9 °C.
  • Using medicines that are harmful to organs or medicines that change how the liver (the organ that processes many drugs) works within 90 days before the study.
  • Using any prescription medication within 28 days before the study, unless it is specific hormonal therapy that has remained at a steady dose for 90 days.
  • Using any over-the-counter medicines, vitamins, herbal treatments, or food supplements within 14 days before the study, except for hormonal contraceptives.
  • Having any sudden or long-term illness that might affect the safety or the results of how the drug works in your body.
  • Having a tattoo, body piercing, or any skin treatment that breaks the skin within 90 days of the screening.
  • Donating a large amount of blood (at least 500 mL) within 90 days, or donating plasma (the liquid part of blood) or platelets (cells that help blood clot) within 14 days.
  • Having anaemia, which is a condition where you lack enough healthy red blood cells, or having low haemoglobin (a protein in red blood cells that carries oxygen) levels.
  • Participating in another clinical study or using an experimental drug or device within 30 days before the study begins.
  • Having veins in the arms that make it difficult or complicated to collect blood samples.
  • A history of severe allergic reactions to the study drug, similar medicines like NSAIDs (non-steroidal anti-inflammatory drugs), aspirin, or other specific substances.
  • A history of heart failure, which is when the heart cannot pump enough blood to meet the body's needs.
  • A history of stomach or intestinal issues, such as ulcers (sores in the lining of the stomach), gastritis (inflammation of the stomach lining), colitis, or Crohn’s disease.
  • Using medications that affect hemostasis (the body's ability to stop bleeding) or those that affect how the liver processes chemicals.
  • Having asthma or other breathing issues that are triggered by certain medications.
  • A history of cardiac arrhythmias (irregular heartbeats) or other blood and clotting disorders.
  • Having received a COVID-19 vaccine less than 14 days before the screening or planning to get one during the study.
  • Having been hospitalized because of COVID-19.
  • Testing positive for the SARS-CoV-2 virus via a PCR or antigen test.
  • Having severe hepatic impairment, which means the liver is not functioning correctly, shown by high levels of certain enzymes in the blood.
  • A history of renal disease, which refers to problems with the kidneys.
  • Experiencing any major illness or undergoing major surgery within 28 days before the study.
  • Testing positive for infections such as Hepatitis B, Hepatitis C, or HIV.
  • Testing positive for drug or alcohol use during screening or check-in.
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Investigated drugs

  • Celecoxib

    is a medication used to reduce pain and inflammation. In this study, it is being tested in two different forms: a liquid suspension and a capsule, to see how well the body absorbs each one.

  • Heparin

    is a medication that helps prevent blood clots from forming in the blood.

What is already known about the treatment

  • Celecoxib

    This medication is taken orally as a capsule or a liquid suspension to help relieve pain and inflammation. It is a well-established medicine used to treat conditions like arthritis and menstrual cramps by blocking specific enzymes in the body that cause swelling and pain. By targeting only certain parts of the inflammatory process, it helps reduce discomfort with a different approach than many older pain relievers. It belongs to a class of drugs known as selective COX-2 inhibitors.

  • Heparin sodium

    This medication is administered through an intravenous injection directly into a vein. It is a widely used substance in hospitals to prevent and treat blood clots. At a molecular level, it works by activating natural substances in the blood to stop the clotting process from happening too quickly. It is classified as an anticoagulant, which is a medicine used to thin the blood.

Investigated diseases

  • Dysmenorrhea

    This condition involves painful cramping in the lower abdomen. It is often associated with the menstrual cycle. The pain typically occurs due to contractions of the uterine muscles. It can vary in intensity and duration during each cycle.

  • Acute pain

    This is a sharp or sudden sensation of discomfort that starts abruptly. It usually serves as a signal that the body has encountered a recent injury or stimulus. The sensation is typically intense but tends to resolve once the underlying cause is addressed.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504052-99-00Protocol code915/22Estimated enrolment54 patientsSponsorCodadose Inc.

sourced from the EU Clinical Trials Register and site verification

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