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

NCT05356143 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-03-23

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Rupatadine

Oral single dose 10 mg tablet

Sponsors & Collaborators

  • J. Uriach and Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-02
Primary Completion
2022-01-13
Completion
2023-01-05
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05356143 on ClinicalTrials.gov