Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subject… (NCT06855576) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions
Germany54 participantsStarted 2025-03-05
Plain-language summary
This study aims to evaluate the bioequivalence of new formulated orodispersible tablet (ODT) containing 500 milligram (mg) paracetamol in comparison to the European marketed Alvedon (paracetamol) 500 mg film-coated tablets and the Australian marketed Panadol (paracetamol) 500 mg film-coated tablets as reference products.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient.
. Existing renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Observed Concentration (Cmax) for Paracetamol ODT (Test) Versus (vs.) Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
2
Area Under the Concentration vs. Time Curve From Dosing Time to the Last Measurement Time Point (AUC0-tlast) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
3
Time to Reach Maximum Concentration (Tmax) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
4
Cmax for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
5
AUC0-tlast for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
. Existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient.
. History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders.
. History or clinical evidence at screening of pancreatic injury or pancreatitis.
. History of inflammatory bowel disease or gastrointestinal bleeding including peptic ulcers.
. Diagnosis of systemic lupus erythematosus, thyroid diseases, secondary Raynaud's syndrome; known hyperkalemia.
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
6
Tmax for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
Timeframe: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period