NCT00649857

CompletedPhase 1

Food Study of Cetirizine HCl Tablets 10 mg and Zyrtec® 10 mg

Mylan Pharmaceuticals Inc Source

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Other study identifiers

Sponsor study identifier

CETI-0287

Study Type

interventional

Actual enrollment (reported)

18

Locations

1 country

Sites

1

Timeline

Study Start

November 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2002

Actual (reported)

Study Completion

December 2002

Actual (reported)

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan's cetirizine HCl tablets to Pfizer's Zyrtec® tablets following a single, oral 10 mg (1 x 10 mg) dose administered under fed conditions.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 18 participants
Study completion date: December 2002
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2002
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2002
Actual (reported)
Study Completion
December 2002
Actual (reported)
First Submitted
March 30, 2008
Actual (reported)
First Posted
April 1, 2008
Actual (reported)

Last Updated: April 24, 2024
Status Verified: April 2024
Last Update Submitted: April 22, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

Bioequivalence
within 30 days

Study Arms (2)

1

EXPERIMENTAL

Cetirizine HCl Tablets 10 mg

Drug: Cetirizine HCl Tablets 10 mg

2

ACTIVE COMPARATOR

Zyrtec® 10 mg

Drug: Zyrtec® 10 mg

Interventions

Cetirizine HCl Tablets 10 mgDrug

10mg, single dose fed

1

Zyrtec® 10 mgDrug

10mg, single dose fed

2

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age: 18 years and older.
Sex: Male and non-pregnant, non-lactating female

Sponsors & Collaborators

Mylan Pharmaceuticals Inc
Industrylead

Study Sites (1)

Novum Pharmaceutical Research Services

Houston, Texas, 77042, United States

MeSH Terms

Interventions

Cetirizine

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

So Ran Hong, M.D.
Novum Pharmaceutical Research Services
PRINCIPAL INVESTIGATOR

Enrollment

18 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 1, 2008

Study Start

November 2002

Date type not reported

This date has not been verified as actual or estimated.

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Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and the evening prior to dosing of each study period. An additional beta-HCG pregnancy test will be performed upon completion of the study.

Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:

hormonal contraceptives initiated at least 3 months prior to the start of the study and continued during the study, or

intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or

barrier methods containing or used in conjunction with a spermicidal agent, or

postmenopausal or surgical sterility accompanied with a documented postmenopausal course of at least one year (tubal ligation, oophorectomy or hysterectomy).

During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form.

Women are allowed to be taking hormone replacement therapy provided that the dosage regimen was initiated at least 3 months prior to the start of the study and continued from study screen until study exit.

Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).

All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

You may not qualify if:

Institutionalized subjects will not be used.
Social Habits:
Use of any tobacco products.
Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.
Any recent, significant change in dietary or exercise habits.
Medications:
Use of any medication within the 14 days prior to the initial dose of study medication, excluding hormonal contraceptives and replacement therapy initiated at least 3 months prior to study medication dosing.
Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication, excluding hormonal contraceptives and replacement therapy initiated at least 3 months prior to study medication dosing.
Diseases:
History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
History of drug and/or alcohol abuse.
Acute illness at the time of either the pre-study medical evaluation or dosing.
Abnormal and clinically significant laboratory test results:
Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
+6 more criteria

Contact the study team to confirm eligibility.

Primary Completion

December 2002

Actual (reported)

Study Completion

December 2002

Actual (reported)

Last Updated

April 24, 2024

Record last verified: 2024-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00649857
Data provider: ClinicalTrials.gov
Source updated: 2024-04-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:22 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations