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New dissolving paracetamol tablet put to the test

NCT ID NCT06855576

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether a new paracetamol tablet that dissolves in the mouth (orodispersible) works the same as two existing paracetamol tablets. Healthy adults aged 18 to 55 take a single dose of each tablet on separate days, and researchers measure how much paracetamol gets into the blood. The goal is to see if the new tablet is a suitable alternative for people who have trouble swallowing pills.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Paracetamol
What this could lead to
If successful, this could provide a new, easier-to-take form of paracetamol that dissolves in the mouth.
What could go wrong
This is an early-phase study in healthy volunteers, so results may not apply to people with pain or fever. The new tablet may not be absorbed identically.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

54 people

The number who actually took part.

Started

Mar 2025

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the participants participating in the clinical trial. * Sex: male/female. * Age: 18 to 55 years (including) * Body-mass index (BMI): more than or equal to (\>=)18.5 kilogram per meter square (kg/m\^2) and less than or equal to (\<=) 30.0 kg/m\^2. * Body weight: \>= 50.0 kg for males and \>= 45.0 kg for females. * Good state of health. * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Female participant of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 7 days after the last dose of assigned treatment. * Non-smoker or ex-smoker for at least 3 months (including non-nicotine vapers, nicotine chewing gum or pouches or nicotine replacement therapy). Exclusion Criteria: * Safety Concerns 1. Existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient. 2. Existing renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient. 3. Current evidence of ongoing hepatic disease or impaired hepatic function at screening. A participant will be excluded if more than one of the following lab value deviations are found: 1) Aspartate aminotransferase (AST) (\>= 1.2 upper limit of normal \[ULN\]), Alanine transaminase (ALT) (\>= 1.2 ULN), 2) Gamma-glutamyl transferase (GGT) (\>= 1.2 ULN), Alkaline phosphatase (ALP) (\>= 1.2 ULN), 3) total bilirubin (greater than \[\>\] 2.00 milligrams per deciliter (mg/dL), except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) or creatine kinase (\>= 3 ULN), and creatinine \> 0.1 mg/dL ULN (limit of \> 0.1 mg/dL correspondents to of \> 9 micromole per liter \[μmol/l\] ULN). A single deviation from the above values is acceptable and will not exclude the candidate, unless specifically advised by the investigator. 4. Existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient. 5. History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders. 6. History or clinical evidence at screening of pancreatic injury or pancreatitis. 7. History of inflammatory bowel disease or gastrointestinal bleeding including peptic ulcers. 8. Diagnosis of systemic lupus erythematosus, thyroid diseases, secondary Raynaud's syndrome; known hyperkalemia. 9. Evidence of urinary obstruction (example, due to benign prostate hyperplasia) or difficulty in voiding at screening. 10. Status of glutathione depletion (eating disorder, cystic fibrosis, human immunodeficiency virus \[HIV\] infection, starvation, cachexia) due to metabolic deficiencies. 11. Oral surgery within 4 weeks of dosing, dental work or extractions within 2 weeks of dosing, or presence of any clinically significant (as determined by the principal investigator or designee) oral pathology including lesions, sores or inflammation. 12. History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling or gastric banding (note: this is not applicable for minor abdominal surgery without significant tissue resection, example, appendectomy and herniorrhaphy). 13. Participants, who report a frequent occurrence of migraine attacks. 14. Acute or chronic diseases which may interfere with the pharmacokinetics of the investigational medicinal product (IMP). 15. Clinically relevant chronic or acute infectious illnesses or febrile infections within two weeks prior to start of the study. 16. History or current evidence of renal disease or impaired renal function at screening as indicated by abnormal levels of serum creatinine (\> 1.43 mg/dL) or blood urea nitrogen (BUN) (\>= 35 mg/dL) or the presence of clinically significant abnormal urinary constituents (example, albuminuria). 17. Systolic blood pressure less than (\<) 90 or \> 139 millimeter of mercury (mmHg). 18. Diastolic blood pressure \< 50 or \> 89 mmHg. 19. Heart rate \< 50 beats per minute (bpm) or \> 90 bpm. 20. Corrected QT interval (QTc) interval \> 450 milliseconds (ms) for men and \> 470 ms for women. 21. Hemoglobin value \< 12.0 grams per deciliter (g/dL) for males and \< 11.5 g/dL for females. 22. Evidence or history of medication overuse headache, or allergic disease to medication within the last 5 years that may increase the risk associated with study participation. 23. Laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator. 24. Positive anti-HIV-test (if positive to be verified by western blot), hepatitis B surface antigen (HBs-AG) test and anti-hepatitis B core immunoglobulin M (HBc IgM) or anti-hepatitis C virus (HCV) test. 25. Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations. 26. Any history of asthma, urticaria, or other significant allergic diathesis or allergic reaction to any other pain reliever/fever reducer. Participant with uncomplicated seasonal allergic rhinitis can be accepted if expected allergy season is clearly outside enrollment/treatment period. 27. History of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator. * Lack of suitability for the clinical trial 1. History of illegal or legal drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana, codeine) within 1 month or hard drugs (such as cocaine, phencyclidine \[PCP\], crack, any opioid derivatives such as heroin or fentanyl, and amphetamine derivatives) within 3 months prior to screening. 2. Positive alcohol, cotinine or drug test at screening examination. 3. History of alcohol abuse in the last 5 years or regular intake of alcoholic food or beverages of \>= 24 gram (g) pure ethanol for men or \>= 12 g pure ethanol for women per day. 4. Participants who are on a diet which could affect the pharmacokinetics of the active ingredient. 5. Regular intake of beverages or food containing xanthine derivatives or xanthine-related compounds (example, coffee, tea, caffeine-containing sodas and chocolate), equivalent to \>= 500 milligram (mg) xanthine per day. 6. Performance of strenuous physical exercise (body building, high performance sports) from 2 weeks prior to admission and throughout the entire study. 7. Participant reports consumption of any drug metabolizing enzyme (example, Cytochrome P450 3A4 (CYP3A4) or other cytochrome P450 enzymes) inducing or inhibiting aliments, beverages or food supplements (example, broccoli, Brussels sprouts, grapefruit, grapefruit juice, star fruit, St. John's Wort and so on) within 2 weeks prior to admission to the unit. 8. Use of any systemic or topical medication (including over the counter \[OTC\] medications, herbal remedies, cannabidiol cosmetics and any anticholinergic medicines or other medicines that may cause dry mouth) within 2 weeks or within less than 10 times the elimination half-life of the respective drug (whichever is longer) before first scheduled study drug administration, or is anticipated to require any concomitant medication during that period or at any time throughout the study. 9. Any history of long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes. 10. Any vaccination, including Coronavirus disease (COVID)-19 vaccine, within 14 days prior to the first dose. 11. Donation of plasma within 7 days prior to dosing or donation or loss of 500 milliliter (mL) or more of whole blood within 8 weeks prior to dosing. 12. Participation in a clinical trial in which they have tried an IMP, a medical device or a marketed medicinal product during the last 6 months prior to individual enrolment of the participant. 13. Simultaneous participation in another clinical trial with active ingredients, medical devices or marketed medicinal products. * For female participants with childbearing potential only 1. Positive pregnancy test at screening examination. 2. Pregnant or lactating women. 3. Female participants who do not agree to apply highly effective contraceptive methods. * Administrative reasons 1. Close affiliation with the sponsor or the investigational site; example, a close relative of the investigator, dependent person (example, employee of or student at the investigational site), employee of the sponsor or affiliates. 2. Participants who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial.

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Conditions

The condition(s) this trial relates to.

Fever Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • SocraTec R&D GmbH

    Erfurt, Thuringia, 99084, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.