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Pharmacokinetics and Safety of Rupatadine in Participants With Hepatic Impairment Compared to Control Participants.

NCT06736340 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-05-28

No results posted yet for this study

Summary

The purpose of this study is to assess the PK and safety of rupatadine (10 mg) and its active metabolites in participants with mild, moderate, or severe hepatic impairment compared to matched control participants with normal hepatic function. The study duration will be up to 38 days, including Screening, Baseline, Study Period, and EOS Visit assessments. Rupatadine 10 mg tablet will be administered as single dose.

Conditions

  • Hepatic Impairment

Interventions

DRUG

Rupatadine

10mg tablets

Sponsors & Collaborators

  • Noucor Health S.A.

    lead INDUSTRY

Principal Investigators

  • Serafim Guimarães, MD · Blueclinical Investigacao E Desenvolvimento Em Saude Lda.

  • Rosa Maria Príncipe, MD · Hospital Pedro Hispano

  • Joana Cochicho, MD · Centro Hospitalar de Vila Nova de Gaia/Espinho

  • Dolores Ochoa Mazarro, MD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  • Ana Maria Aldea Perona, MD · Municipal Institute Of Medical Investigation

  • Germán Soriano Pastor, MD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  • Alberto Borobia Pérez, MD · Hospital Universitario La Paz

  • Antonio Portolés Pérez, MD · Hospital Clinico San Carlos

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-17
Primary Completion
2025-04-09
Completion
2025-04-09
FDA Drug
Yes

Countries

  • Portugal
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06736340 on ClinicalTrials.gov