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Cetirizine Chewable Bioequivalence and Food Effect Study

NCT03772158 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-12-01

No results posted yet for this study

Summary

The purpose of this study is to determine and compare the amount of study drug that gets into your blood after the administration of each of the three formulations of cetirizine under different conditions. Another objective of this study is to evaluate the effect of food on the amount of study drug that gets into your blood after the administration of the investigational formulation. Other objectives of this study are to determine the sensory experience and ease of swallowing the investigational formulation, as well as to determine the safety of test and reference formulations of cetirizine.

Conditions

  • Allergy

Interventions

DRUG

Cetirizine 10mg

Chewable tablet

DRUG

Cetirizine 10 mg

Immediate Release Tablet

DRUG

Cetirizine 10 mg

Immediate Release Tablet

Sponsors & Collaborators

  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, MD · Algorithme Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2019-02-03
Completion
2019-02-03
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 NCT03772158 on ClinicalTrials.gov