NCT00881127

Brief Summary

To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fasting conditions.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
Last Updated

March 28, 2017

Status Verified

April 1, 2009

Enrollment Period

Same day

First QC Date

April 13, 2009

Last Update Submit

March 27, 2017

Conditions

Allergies

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    10 days

Study Arms (2)

1

EXPERIMENTAL

Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)

Drug: Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)

2

ACTIVE COMPARATOR

Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)

Drug: Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)

Interventions

Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)DRUG
1
Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)DRUG
2

Eligibility Criteria

Age24 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Xueyu (Eric) Chen, M.D.

    Pharma Medica Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 15, 2009

Study Start

July 1, 2005

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

March 28, 2017

Record last verified: 2009-04