RecruitingPhase 1NCT06708520

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

A Study to Investigate Pharmacokinetics and Safety of Rupatadine (10 mg) and Its Active Metabolites in Participants With Renal Impairment Compared to Matched Control Participants With Normal Renal Function

Sponsor

Noucor Health S.A.

Enrollment

48 participants

Start Date

Nov 21, 2022

Study Type

INTERVENTIONAL

Conditions

Renal Impairment

Summary

The purpose of this study is to assess the PK, tolerability, and safety of rupatadine (10 mg) and its active metabolites in participants with renal impairment compared to matched control participants with normal renal function. The study duration will be up to 40 days, including Screening, Baseline, Study Period, and EOS visit assessments. Rupatadine 10 mg tablet will be administered as single dose.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Rupatadine for people with renal impairment. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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