NCT05356143

A Comparative Study of Rupatadine 10 mg Tablets and Clarinex® 5 mg Tablets Under Fasting Conditions

A Single-Dose, Partial-Replicate, Pharmacokinetic, and Comparative Bioavailability Study of Rupatadine 10 mg Tablets and Clarinex® 5 mg Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: J. Uriach and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single-dose, randomized, three-period, two-treatment, threesequence, crossover, PK, partial replicate, and comparative bioavailability study. This study may be conducted in groups. The same protocol requirements and procedures will be followed for each group.

Detailed description

This study will allow for the determination of the PK and intra-subject variability of rupatadine and metabolites. In addition, this study will compare the bioavailability of the rupatadine formulation (Drug Product 1) to a FDA-approved reference product (Clarinex®) (Drug Product 2) as far as the rupatadine metabolite desloratadine, and the derived compounds, is concerned. Comparative bioavailability between Drug Product 1 and Drug Product 2 will be determined by a statistical comparison of the AUCt, AUCinf, and Cmax parameters for desloratadine (UR-12790), 3-OH desloratadine (UR-12788), 5-OH desloratadine (UR-12767), 6-OH desloratadine (UR-12766), and 3-OH-glucuronide-desloratadine (UR-12335).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rupatadine	Oral single dose 10 mg tablet

Timeline

• Start date: 2021-12-02
• Primary completion: 2022-01-13
• Completion: 2023-01-05
• First posted: 2022-05-02
• Last updated: 2023-03-23

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study