SYF857528641dbe4c50bfb35354affc65e1

UnknownPhase 1

Bioequivalence clinical trial of two formulations of rosuvas...

Laboratorios Normon S.A.Source

Laboratorios Normon S.A.

CTIS (EMA)

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Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Brief Summary

To evaluate the relative bioavailability of the test formulation of rosuvastatin/ezetimibe compared to the commercial formulation taken as reference and to demonstrate their bioequivalence according to health authorities’ criteria.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 29, 2022
Actual (reported)

Conditions

Healthy volunteers

Outcome Measures

Primary Outcomes (2)

Rosuvastatine AUC0-t and Cmax.
Total ezetimibe: AUC0-72 and Cmax.

Secondary Outcomes (2)

Rosuvastatine: AUC0-∞, Tmax and residual area.
Total Ezetimibe: Tmax.

Interventions

Rosuvastatina/Ezetimiba Normon 20 mg/10 mg comprimidos recubiertos con películaType not reported

Lipocomb 20 mg/10 mg cápsulas durasType not reported

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 Normon S.A.
Industrylead

Study Sites (1)

Hospital Universitario De La Princesa

Madrid, 28006, Spain

Dolores Ochoa+34915202247 dochoa@iis-princesa.org

Central Study Contacts

Carlos Govantes (R&D Director)

+34918065240 cgovantes@normon.com

Study Design

Study Type: interventional
Phase: phase 1

Study Record Dates

First Submitted

September 29, 2022

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: 2022-501862-24-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 03:16:24 UTC

Documents

Synopsis_FR_N-ROSEZE-22-274

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No clinically significant organic or psychic conditions.

No clinically significant abnormalities in medical records and physical examination.

No clinically significant abnormalities in haematology, coagulation, biochemistry, serology (Ag HBs, HC antibodies, HIV antibodies) and urinalysis (see Appendix C).

No clinically significant abnormalities in vital signs and electrocardiogram.

You may not qualify if:

Subjects affected by an organic or psychic condition. Before a volunteer is included, all the safety parameters defined in points 7.3 will be considered. Those who present clinically significant analytical alterations and in whom biochemical kidney and/or liver damage markers are outside the normal range applied by the laboratory will be excluded [GOT, GPT and/or GGT >2.5*ULN and total bilirrubin >1.5*ULN (total bilirrubin >1.5*ULN is acceptable if the direct bilirrubin is <35%)].
Subjects who have received prescribed pharmacological treatment in the last 15 days or any kind of medication in the 48 hours prior to receiving the study medication, but women are allowed taking contraceptives. Contraceptive methods must be used at least 4 weeks prior to entry visit and not to be changed for the duration of the study.
Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.
History of sensitivity to any drug.
Positive drug screening (for cannabis, opiates, cocaine and amphetamines).
Smoker.
Daily consumers of alcohol and/or acute alcohol poisoning in the last week.
Having donated blood in the last month before start of the study.
Pregnant or breastfeeding women. Child-bearing age women participating in the study will compromise to use a high effective contraceptive method (see Appendix D) or will be abstinent during their participation in the study.
Participation in another study with administration of investigational drugs in the previous 3 months (if the study was conducted with drug substances marketed in Spain, a period of at least 1 month or 5 half lives, what is longer, will be considered).
Inability to follow the instructions or collaborate during the study.
History of difficulty in swallowing.

Contact the study team to confirm eligibility.

Resumen persona lega_IF_N-ROSEZE-22-274

Synopsis Lay person_FR_N-ROSEZE-22-274

Final report_N-ROSEZE-22-274_Censurado

Locations

ES(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Interventions

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