Bioequivalence Study of Paracetamol With Oral Single Dose... | NCT06855576

NCT06855576

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2024-514198-23-00	EU Trial (CTIS) Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Product	Experimental	Participants will be randomly assigned as per cross-over design to receive oral administration of one paracetamol ODT (test product) on day 1 of period 1, one Alvedon film-coated tablet (reference product 1) on day 1 of period 2 and one Panadol film-coated tablet (reference product 2) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days).	Drug: Paracetamol ODT Drug: Alvedon film-coated tablet Drug: Panadol film-coated Tablet
Reference Product 1	Active Comparator	Participants will be randomly assigned as per cross-over design to receive oral administration of one Alvedon film-coated tablet (reference product 1) on day 1 of period 1, one Panadol film-coated tablet (reference product 2) on day 1 of period 2 and one paracetamol ODT (test product) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days).	Drug: Paracetamol ODT Drug: Alvedon film-coated tablet Drug: Panadol film-coated Tablet
Reference Product 2	Active Comparator	Participants will be randomly assigned as per cross-over design to receive oral administration of one Panadol film-coated tablet (reference product 2) on day 1 of period 1, and one paracetamol ODT (test product) on day 1 of period 2 and one Alvedon film-coated tablet (reference product 1) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days).	Drug: Paracetamol ODT Drug: Alvedon film-coated tablet Drug: Panadol film-coated Tablet

Name	Type	Description	Arm Group Labels	Other Names
Paracetamol ODT	Drug	Experimental Paracetamol 500 mg ODT	Reference Product 1 Reference Product 2 Test Product

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Observed Concentration (Cmax) for Paracetamol ODT (Test) Versus (vs.) Paracetamol (Alvedon Film-coated Tablet) (Reference 1)	Cmax was defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples were collected at indicated timepoints for the analysis of Cmax. Pharmacokinetic (PK) parameters were determined by non-compartmental analysis.	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
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)	AUC0-tlast was defined as area under the concentration vs. time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations). Blood samples were collected at indicated timepoints for the analysis of AUC0-tlast. PK parameters were determined by non-compartmental analysis.	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
Time to Reach Maximum Concentration (Tmax) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)	Blood samples were collected at indicated timepoints for the analysis of tmax. PK parameters were determined by non-compartmental analysis.	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
Cmax for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Plasma Concentration vs. Time Curve Calculated From Time Zero to Infinity [AUC (0-inf)] for Paracetamol ODT (Test)	AUC (0-inf) equal to(=) AUC0-tlast addition(+) AUCexpol, where AUCexpol = Clast/Lz, where Clast was observed concentration at the last time point with a concentration value above the lower limit of quantitation, directly taken from measured concentration values and Lz was apparent terminal elimination rate constant determined by log-linear regression(Lz); the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of AUC (0-inf). PK parameters were determined by non-compartmental analysis.

Eligibility Module

Eligibility Criteria

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.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
SocraTec R&D GmbH		Erfurt	Thuringia	99084	Germany

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

A total of 54 participants were enrolled and randomized to treatment groups. A total of 52 randomized participants subsequently completed the study.

Arm/Group Information

ID	Title	Description
FG000	Test Product/ Reference Product 2/ Reference Product 1	Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol Orodispersable Tablet (ODT) (test product) on day 1 of period 1, one Panadol film-coated tablet (reference product 2) on day 1 of period 2 and one Alvedon film-coated tablet (reference product 1) on day 1 of period 3, each under fasting conditions. There was at least 72 hours of washout between each period (no more than 7 days).
FG001	Reference Product 1/ Test Product/ Reference Product 2	Participants were randomly assigned as per cross over design to receive oral administration of one Alvedon film-coated tablet (reference product 1) on day 1 of period 1, one paracetamol ODT (test product) on day 1 of period 2 and one Panadol film-coated tablet (reference product 2) on day 1 of period 3, each under fasting conditions. There was at least 72 hours of washout between each period (no more than 7 days).
FG002	Reference Product 2/ Reference Product 1/ Test Product	Participants were randomly assigned as per cross over design to receive oral administration of one Panadol film-coated tablet (reference product 2) on day 1 of period 1, one Alvedon film coated tablet (reference product 1) on day 1 of period 2, and one paracetamol ODT (test product) on day 1 of period 3, each under fasting conditions. There was at least 72 hours of washout between each period (no more than 7 days).

Periods

Title

Milestones

Reasons Not Completed

Treatment Period 1 (1 Day)

Type	Comment	Milestone Data
STARTED		FG00018 subjects FG00118 subjects FG00218 subjects
COMPLETED		FG00018 subjects FG00118 subjects FG00218 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects

Washout Period 1 (3 Days)

Type	Comment	Milestone Data
STARTED		FG00018 subjects FG00118 subjects FG00218 subjects
COMPLETED		FG000

Treatment Period 2 (1 Day)

Type	Comment	Milestone Data
STARTED		FG00018 subjects FG00117 subjects FG00218 subjects
COMPLETED		FG000

Washout Period 2 (3 Days)

Type	Comment	Milestone Data
STARTED		FG00017 subjects FG00117 subjects FG00218 subjects
COMPLETED		FG000

Treatment Period 3 (1 Day)

Type	Comment	Milestone Data
STARTED		FG00017 subjects FG00117 subjects FG00218 subjects
COMPLETED		FG000

Washout Period 3 (3 Days)

Type	Comment	Milestone Data
STARTED		FG00017 subjects FG00117 subjects FG00218 subjects
COMPLETED		FG000

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Overall Study Participants	Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol ODT (test product), one Alvedon film-coated tablet (reference product 1) and one Panadol film-coated tablet (reference product 2) as per randomization schedule. There was at least 72 hours of washout period between each period (no more than 7 days).

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Maximum Observed Concentration (Cmax) for Paracetamol ODT (Test) Versus (vs.) Paracetamol (Alvedon Film-coated Tablet) (Reference 1)

Cmax was defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples were collected at indicated timepoints for the analysis of Cmax. Pharmacokinetic (PK) parameters were determined by non-compartmental analysis.

The PKAS (pharmacokinetics analysis set) was defined as all participants in the PK population who completed at least two periods with one test formulation and who had no major protocol deviations concerning pharmacokinetics. The PK population was defined as all randomised participants who had at least one measurable PK parameter. Only those participants with data available at the specified timepoint were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms per milliliter(µg/mL)

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

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Test Product	Participants were randomly assigned as per cross over design to receive oral administration of one paracetamol (ODT) as per randomization schedule. There was at least 72 hours of washout between each period (no more than 7 days).

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal distension	Gastrointestinal disorders		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Haleon Response Center	HALEON	+441932959500		ww.clinical-trial-register@haleon.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 7, 2024	Apr 1, 2026	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Mar 28, 2025	Apr 1, 2026	SAP_001.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D005334	Fever
D010146	Pain

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Cmax was defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.

EG0001 affected53 at risk

EG0010 affected53 at risk

EG0020 affected53 at risk