Trials Sponsors Conditions Drugs Pricing

Conditions

healthy

Outcome Measures

Primary Outcomes (2)

For oral administration, blood samples will be collected at pre-dose and 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 12h and 24h after study drug administration. For intranasal administration, blood samples will be collected at pre-dose and 5, 10, 15, 30, 45 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after study drug administration.
Vital signs pre-dose, (blood pressure, heart rate and body temperature) at 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 24h post-dose.

Interventions

Zolmitriptán Normon 5 mg comprimidos bucodispersables EFG.Type not reported

Zomig 5 mg solución para pulverización nasalType 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
Zolmitriptán Normon 5 mg comprimidos bucodispersables EFG.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORODISPERSIBLE TABLET
View registry record
Formulated product
Zomig 5 mg solución para pulverización nasal
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
NASAL SPRAY, SOLUTION
View registry record

Ingredients named in source formulations

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

Zolmitriptán Normon 5 mg comprimidos bucodispersables EFG.
Named ingredient: zolmitriptan
View registry record
Zomig 5 mg solución para pulverización nasal
Named ingredient: zolmitriptan
View registry record

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy male and female healthy subjects.
Age ≥ 18 and≤ 55 years.

Sponsors & Collaborators

Parc De Salut Mar
Type not reportedlead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (1)

Parc De Salut Mar

Barcelona, 08003, Spain

Ana Maria Aldea-Perona+34933160490 aaldea@imim.es

Central Study Contacts

Marta Lopez OTero

+34933160576 mlopez4@imim.es

Study Design

Study Type: interventional
Phase: phase 1

Study Record Dates

First Submitted

April 5, 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: 2023-504492-24-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-29 05:38:50 UTC

Documents

Summary of ZOL results

You may not qualify if:

Life-time substance use disorders (SUD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Use of drugs known to induce or inhibit hepatic drug metabolism within one month prior to study administration or during the study and use of citrus juice during the study.
Use of known monoamine oxidase A (MAO-A) and monoamine oxidase B (MAO-B) inhibitors within one month prior to study administration or during the study.
Use of ergot-containing drugs and 5-HT1B/1D agonists (e.g., dihydroergotamine and methysergide) or 5-HT1B/1D agonists within 24 h of using zolmitriptan nasal spray.
Any prescription or over the counter (OTC) product including herbal, homeopathic, vitamins, minerals and nutritional supplements within 2 weeks prior to study drug administration except for oral contraceptives.
Intake of foods or beverages containing xanthine (more than 5 units of coffee, tea or cola drinks per day).
Donation of blood or plasma within one month prior to study drug administration or transfusion of blood or plasma for medical/surgical reasons or intention to donate blood or plasma within one month after study drug administration.
History of inadequate venous access and/or experience of difficulty donating blood.
Not able/not willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine containing items when out of CRU.
Subject included in an investigational clinical study within 3 months prior to study drug administration.
Positive blood or urine test for drugs of abuse or alcohol breath test prior to study drug administration
History of anxiety or depression not completely recovered within 12 months prior to study drug administration, as assessed by the DDSI.
Any other clinically relevant disease or condition that in the judgment of the investigator might interfere with the subject’s ability to comply with study procedures or requirements and/or bias the interpretation of the study results and/or jeopardize the subject’s safety.
Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption.
Any clinically relevant findings in physical examination, vital signs, ECG and safety laboratory parameters in the opinion of the PI or CI.
+3 more criteria

Physiologically based pharmacokinetic modelling of oral and intranasal formulations of zolmitriptan in healthy volunteers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

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 (2)

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