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.
Participant understands the study procedures and agrees to participate in the study by giving written informed consent prior to any study-mandated procedure.
Able to communicate well with the Investigator, to understand and comply with the study requirements.
Willing to comply with study restrictions stated in Section 5.3 (lifestyle considerations).
Male or female Caucasian subjects, between 18 and 75 years (inclusive) of age.
Pregnant or lactating women.
Participant is unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for the EOS Visit and improbability of completing the clinical study.
Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the participant to comply with the protocol requirements
History of hypersensitivity to rupatadine, desloratadine or any of the excipients, or to medicinal products with similar chemical structures.