HealthyNCT00776139
Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fasting Conditions
A study testing Cetirizine Hydrochloride 10 mg tablet in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
Trial summary
An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cetirizine Hydrochloride 10 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-50 years.
- Were within 18 to 29.9 kilograms/m2 per the BMI (Determination of Body Mass Index).
- Had voluntarily given written informed consent to participate in this study.
- Were of normal health as determined by medical history and physical examination of the subjects performed within 30 days prior to the commencement of the study.
- Blood chemistry, hematology, and urinalysis tests performed within 30 days prior to the start of the study must be within clinically acceptable limits upon evaluation by the Investigator.
- Subjects must have screening and check-in (each period) blood pressure and pulse rate within the protocol specified ranges.
- If female and of childbearing potential, the subject was counseled on the importance of not becoming pregnant before or during the study, and the subject had a negative pregnancy test at the pre-treatment visit.
Who cannot join
- History of clinically significant organ-system (cardiovascular, neurological, hepatic, hematopoietic, pulmonary, endocrine, or gastrointestinal) disorders, or ongoing infectious diseases.
- history of alcohol abuse or drug addiction requiring treatment within the last 12 months.
- Presence or history of renal impairment or chronic liver disease.
- History of jaundice (yellowing of the skin or whites of the eyes).
- Participation in an investigationaldrug study or donation of blood within 30 days prior to the start of the study.
- Known allergy or sensitivity to cetirizine (Zyrtec®), or to related drugs such as hydroxyzine (Vistaril® or Ataraxl®).
Show all 12Show fewer
- Prescription drug use (excluding hormonal contraceptives) within 14 days prior to drug administration, each period. Subject is taking macrolide antibiotics, such as erythromycin, azithromicin, ketoconazole, or related drugs.
- Ingestion of grapefruit juice or grapefruit-containg products within 72 hours prio to drug administration, each period.
- Alcohol consumption 24 hours prior to drug administration, each period.
- Caffeine or xanthine consumption for at least 10 hours prior to drug administration, each period.
- Female subjects who are pregnant or nursing.
- Positive HIV 1, Hepatitis B surface antigen, and urine screen for drugs of abuse within 30 days prior to the start of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bioanalytical Systems, Inc.
Baltimore, Maryland, 21201
About this study
Official title: An Open Label, Randomized, Single-Center, Single-Dose, Two-Treatment, Two-Period, Crossover Bioavailability Study Comparing Cetirizine Hydrochloride 10 mg Tablet of Ohm Laboratories Inc. (A Subsidiary of Ranbaxy, Inc) With Zyrtec® Cetirizine Hydrochloride, 10 mg Tablet of Pfizer Labs (Division of Pfizer Inc.) in Healthy, Adult, Human Subjects Under Fasting Condition
An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc. (A subsidiary of Ranbaxy, Inc) with Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of Pfizer Labs (Division of Pfizer Inc.) in healthy, adult, human subjects under fasting condition
Read the detailed description
The study was conducted as an open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability of the test formulation of cetirizine hydrochloride tablet of Ohm Laboratories Inc. (A subsidiary of Ranbaxy, Inc) containing containing 10 mg cetirizine hydrochloride study comparing to the marketed product, Zyrtec®, containing 10 mg of cetirizine hydrochloride of Pfizer Labs (Division of Pfizer Inc.), in healthy, adult, human, subjects under fasting condition.
Safety measures were performed throughout the study and included a physical examination, laboratory evaluation, and measurement of vital signs.
A total of 32 subjects were randomized to receive single oral dose of cetirizine hydrochloride 10 mg tablet and 31 subjects completed both the periods of the study.
- Conditions
- Healthy
- Being tested
- Cetirizine Hydrochloride 10 mg tablet
- Keywords
- Cetirizine Hydrochloride 10 mg tablet fasting conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetirizine Hydrochloride 10 mg tabletDrug
Bioequivalence Cetirizine Hydrochloride 10 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc. Receives: Drug: Cetirizine Hydrochloride 10 mg tablet |
| 2 | Experimental | Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of Pfizer Labs Receives: Drug: Cetirizine Hydrochloride 10 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startOct 2004
- Primary completionOct 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776139
- Sponsor's protocol ID
- 11821
- Status last verified
- Oct 2008
- First submitted
- 17 Oct 2008
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single-Center, Single-Dose, Two-Treatment, Two-Period, Crossover Bioavailability Study Comparing Cetirizine Hydrochloride 10 mg Tablet of Ohm Laboratories Inc. (A Subsidiary of Ranbaxy, Inc) With Zyrtec® Cetirizine Hydrochloride, 10 mg Tablet of Pfizer Labs (Division of Pfizer Inc.) in Healthy, Adult, Human Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT00776139
- Acronym / sponsor ID
- 11821
- Conditions
- Healthy
- Keywords
- Cetirizine Hydrochloride 10 mg tablet fasting conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc. (A subsidiary of Ranbaxy, Inc) with Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of Pfizer Labs (Division of Pfizer Inc.) in healthy, adult, human subjects under fasting condition
Detailed description
The study was conducted as an open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability of the test formulation of cetirizine hydrochloride tablet of Ohm Laboratories Inc. (A subsidiary of Ranbaxy, Inc) containing containing 10 mg cetirizine hydrochloride study comparing to the marketed product, Zyrtec®, containing 10 mg of cetirizine hydrochloride of Pfizer Labs (Division of Pfizer Inc.), in healthy, adult, human, subjects under fasting condition.
Safety measures were performed throughout the study and included a physical examination, laboratory evaluation, and measurement of vital signs.
A total of 32 subjects were randomized to receive single oral dose of cetirizine hydrochloride 10 mg tablet and 31 subjects completed both the periods of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cetirizine Hydrochloride 10 mg tabletCetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc. |
| 2 | Experimental | Drug: Cetirizine Hydrochloride 10 mg tabletZyrtec® Cetirizine Hydrochloride, 10 mg tablet of Pfizer Labs |
Who may qualify
- Ages
- 18 to 50 years
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18-50 years.
- Were within 18 to 29.9 kilograms/m2 per the BMI (Determination of Body Mass Index).
- Had voluntarily given written informed consent to participate in this study.
- Were of normal health as determined by medical history and physical examination of the subjects performed within 30 days prior to the commencement of the study.
- Blood chemistry, hematology, and urinalysis tests performed within 30 days prior to the start of the study must be within clinically acceptable limits upon evaluation by the Investigator.
Key exclusion criteria (12 listed)
- History of clinically significant organ-system (cardiovascular, neurological, hepatic, hematopoietic, pulmonary, endocrine, or gastrointestinal) disorders, or ongoing infectious diseases.
- history of alcohol abuse or drug addiction requiring treatment within the last 12 months.
- Presence or history of renal impairment or chronic liver disease.
- History of jaundice (yellowing of the skin or whites of the eyes).
- Participation in an investigationaldrug study or donation of blood within 30 days prior to the start of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetirizine Hydrochloride 10 mg tabletBioequivalence Cetirizine Hydrochloride 10 mg tablet | Drug | 1, 2 |
Primary outcome
Bioequivalence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2008.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cetirizine Hydrochloride 10 mg tablet in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2008; AzTrials last refreshed its copy on 8 Nov 2026.