Trials Sponsors Conditions Drugs Pricing

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

AUC0-t and Cmax of montelukast

Secondary Outcomes (1)

AUC0-∞, Tmax and residual area of montelukast.

Interventions

Montelukast 10 mg capsulasType not reported

Singulair 10 mg comprimidos recubiertos con películaType 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
Montelukast 10 mg capsulas
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry record
Formulated product
Singulair 10 mg comprimidos recubiertos con película
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

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

Montelukast 10 mg capsulas
Named ingredient: montelukast
View registry record
Singulair 10 mg comprimidos recubiertos con película
Named ingredient: montelukast
View registry record

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male or female subjects who, after receiving information about the design, the objectives of the project, the possible risks that could be derived from it and the fact that they can refuse to collaborate at any time, give their written consent to participate in the study.
Aged from 18 to 55.

Sponsors & Collaborators

Laboratorios Alter S.A.
Industrylead

Study Sites (1)

Hospital Universitario De La Princesa

Madrid, 28006, Spain

Dolores Ochoa Mazarro+34915202247 dochoa@iis-princesa.org

Central Study Contacts

Carmen Morillo Alonso

+34913433320 mcmorilloa@grupo-alter.com

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: 2023-506937-30-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 04:00:59 UTC

Documents

Summary Final report_UECHUP-MON-23-4

Randomised, crossover bioequivalence clinical trial of montelukast 10 mg capsules vs montelukast 10 mg film-coated tablets, after a single oral dose administration to 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