Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy volunteers under fasting conditions

Outcome Measures

Primary Outcomes (1)

· AUC0-t: Area under the plasma concentration-time curve from administration (t = 0) to the last observed concentration at time t (where t is the last time point with a measurable concentration) calculated according to the linear trapezoidal rule. · Cmax: Observed maximum plasma concentration (peak exposure).

Secondary Outcomes (1)

Secondary endpoints of bioavailability evaluated after the administration of a single dose will be: AUC0-∞, tmax, t1/2, lz, CL/F, V/F of paracetamol. Variables obtained in the safety evaluations will be also evaluated: adverse events recordings, vital signs, laboratory tests and ECG recordings.

Interventions

apiretal 500 mg comprimidos bucodispersablesType not reported

Apiretal 100 mg/ml solución oralType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
apiretal 500 mg comprimidos bucodispersables
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORODISPERSIBLE TABLET
View registry record
Formulated product
Apiretal 100 mg/ml solución oral
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORAL SOLUTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

apiretal 500 mg comprimidos bucodispersables
Named ingredient: Paracetamol
View registry record
Apiretal 100 mg/ml solución oral
Named ingredient: Paracetamol
View registry record

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

The subjects must meet all the following criteria at screening in order to be included in the study: 1.- Subjects of either gender (male or female) aged ≥18 and ≤50 years at the time of the enrolment. 2.- Subjects free from organic or psychic conditions. 3.- No clinically significant abnormalities in medical records and physical examination at screening. 4.- No clinically significant abnormalities in haematology, biochemistry, serology (HBsAg, HCV antibodies, HIV antibodies) and urine drug results. 5.- Vital signs (blood pressure, respiratory rate, body temperature and pulse rate) and electrocardiogram record without clinically significant abnormalities. 6.- Body weight within the range (BMI ≥ 18.5 and ≤30.0 kg/m2) expressed as weight (kg) / height (m2). 7.- Subjects must be willing to use a medically acceptable barrier method of contraception throughout the study. Hormonal contraceptives and intrauterine hormone-releasing system (IUS) are not permitted. 8.- Free acceptance to participate in the study by obtaining signed informed consent form approved by the Ethics Committee of the Hospital (CEIm).

Sponsors & Collaborators

Laboratorios Ern S.A.
Industrylead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Rosa María Antonijoan Arbós935537855 rantonijoana@santpau.cat

Central Study Contacts

Francisco Jiménez Esteller

+3493148011 fjim@ern.es

Study Design

Study Type: interventional
Phase: phase 1

Study Record Dates

First Submitted

July 13, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-504815-34-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 03:41:13 UTC

Documents

BESPA_ODT_20240828_Summary of results_Final_V1_SPA_FP

You may not qualify if:

Subjects who fulfil or develop during the study one or more of the following criteria are NOT eligible to participate in this study: 1.- Background of allergy, idiosyncrasy or hypersensitivity to IMP or any related products (including excipients of the formulations). 2.- Heavy consumer of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks per day). 3.- Background History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol > 40 gr/day for men or 24 gr/day for women.4.- Intake of any medication within 14 days prior to taking the study treatment (except for use of ibuprofen short-term symptomatic treatments, according to the investigator criteria), or intake of over-thecounter products (including natural food supplements, vitamins and medicinal plants products) within 7 days prior taking the study treatment. 5.- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results. 6.- Positive results for abuse drugs in urine test or ethanol in breath test (Day-1). 7.- Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases. 8.- Females with positive results from the pregnancy test or breast-feeding. 9.- Smoking within 6 months prior to the study treatment phase (Period 1, Day -1). Smokers must refrain from any tobacco usage, including smokeless tobacco, nicotine patches, electronic cigarettes, etc. at least for 6 months prior to study treatment. 10.- To have participated in another clinical trial during the 3 months prior to study start (screening visit) in which an investigational drug, medical device or a commercially available drug was tested. 11.- To have donated blood within the 4 weeks period before screening visit. 12.- Having undergone major surgery during the previous 6 months before screening visit, or have an intervention programmed during the study. 13.- Mentally or legally incapacitated at screening. 14.- Unwillingness or inability to follow the procedures outlined in the protocol. 15.- Volunteers who have difficulties in understanding the language in which the volunteer information is given. 16.- Any condition that, in the opinion of the investigator, may jeopardise the patient’s well-being or the trial conduct according to the protocol.

A single dose, randomized, open-label, three-way crossover study to assess bioequivalence of paracetamol orodispersible tablets 500 mg vs Apiretal® 100 mg/ml oral solution in healthy volunteers under fasting conditions

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations