At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
Rupatadinedrug
Likely dose
Rupatadine 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Investigate Pharmacokinetics and Safety of Rupatadine (10 mg) and Its Active Metabolites in Participants With Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function.
In Brief
A Phase 1 clinical trial evaluating Rupatadine for Hepatic Impairment. Completed, enrolled 26 participants across 7 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment
CountriesPortugal, Spain
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
Enrollment StartNov 2022
First PostedDec 2024
Primary CompletionApr 2025
TodayJul 2026
First PostedDec 16, 2024
Enrollment StartNov 17, 2022
Primary CompletionApr 9, 2025
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 1.5 years ago
Interventions
Rupatadinedrug
10mg tablets