Completed
A Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fasting Conditions
What is being tested
Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)
+ Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)
Drug
Who is being recruted
Hypersensitivity
+ Immune System Diseases
From 24 to 54 Years
+3 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: July 2005
Summary
Principal SponsorSandoz
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2005
Actual date on which the first participant was enrolled.To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fasting conditions.
Official TitleA Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fasting Conditions
Principal SponsorSandoz
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 24 to 54 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
HypersensitivityImmune System Diseases
Criteria
1 inclusion criteria required to participate
No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
2 exclusion criteria prevent from participating
Positive test results for HIV or hepatitis B or C.
Treatment for drug or alcohol dependence.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalCetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)
Group II
Active ComparatorZyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers