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.
Parallel
Rupatadine
Drug10 mg tablets
Area under the plasma concentration-time curve from time zero to last timepoint (AUC0-t) of rupatadine
To assess the pharmacokinetics (PK), including the area under the plasma concentration-time curve from time zero to last timepoint (AUC0-t), of rupatadine after administration of a single dose of 10 mg in participants with mild, moderate, and severe renal impairment in comparison to participants with normal renal function (control)
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of rupatadine
To assess the pharmacokinetics (PK), including the area under the plasma concentration-time curve from time zero to infinity (AUC0-inf), of rupatadine after administration of a single dose of 10 mg in participants with mild, moderate, and severe renal impairment in comparison to participants with normal renal function (control)
Peak plasma concentration (Cmax) of rupatadine
To assess the pharmacokinetics (PK), including the peak plasma concentration (Cmax), of rupatadine after administration of a single dose of 10 mg in participants with mild, moderate, and severe renal impairment in comparison to participants with normal renal function (control)
Time of maximum plasma concentration (tmax) of rupatadine
To assess the pharmacokinetics (PK), including the time of maximum plasma concentration (tmax) of rupatadine, of rupatadine after administration of a single dose of 10 mg in participants with mild, moderate, and severe renal impairment in comparison to participants with normal renal function (control)
Area under the plasma concentration-time curve from time zero to last timepoint (AUC0-t) of unbound (free) rupatadine
To assess the PK parameters of unbound (free) rupatadine, including the area under the plasma concentration-time curve from time zero to last timepoint (AUC0-t)
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of unbound (free) rupatadine
To assess the PK parameters of unbound (free) rupatadine, including the area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Peak plasma concentration (Cmax) of unbound (free) rupatadine
To assess the PK parameters of unbound (free) rupatadine, including the peak plasma concentration (Cmax)
Time of maximum plasma concentration (tmax) of unbound (free) rupatadine
To assess the PK parameters of unbound (free) rupatadine, including the time of maximum plasma concentration (tmax)
The relationship between renal function (estimated glomerular filtration rate [eGFR] using modification of diet in renal disease equation) and PK parameters (AUC0-t and Cmax) for rupatadine and its metabolites in terms of plasma concentrations
The relationship between renal function (estimated glomerular filtration rate \[eGFR\] using modification of diet in renal disease equation) and PK parameters (AUC0-t and Cmax) for rupatadine and its metabolites in terms of plasma concentrations will be modeled using a regression approach
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