Pharmacokinetics and Safety of Rupatadine (10 mg) in Participants With Renal Impairment Compared to Matched Controls With Normal Renal Function

What this Trial Is About

Researchers are assessing how the drug rupatadine (10 mg) and its active metabolites behave in the bodies of participants with kidney problems compared to those with normal kidney function. The study focuses on the drug's pharmacokinetics (how it is absorbed, distributed, metabolized, and excreted), its tolerability, and safety. This open-label, non-randomized study includes adult participants with varying degrees of renal impairment and matched controls without kidney issues. Participants will receive a single 10 mg dose of rupatadine after fasting overnight. The study involves a Screening period up to 28 days before dosing, a Baseline evaluation one day before dosing, a dosing day, and an End of Study visit occurring 8 days after dosing for those with normal kidney function and 12 days for those with renal impairment. Blood samples for drug level measurements and safety assessments will be collected frequently during the study, with participants staying at the clinic from one day before dosing until 24 hours after dosing. Participants will undergo various assessments including blood draws to monitor drug levels over time and safety evaluations such as vital signs, ECGs, and laboratory tests. The study will measure detailed pharmacokinetic parameters like peak plasma concentration, half-life, and clearance of rupatadine and its metabolites. The total participation time is up to approximately 40 days, covering all study visits and assessments.

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