HealthyPhase 1NCT01064102
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition
A Phase 1 study testing Cetirizine Hydrochloride in people with Healthy, run by Dr. Reddy's Laboratories Limited.
Trial summary
A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys laboratories with Zyrtec 10 mg of Pfizer labs in Healthy Adult Human Male Subjects Under Fasting Conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cetirizine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Feb 2006
- Phase
- Phase 1
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
- Having a Body Mass Index (BMI) between 18.5 and 24.9 {both inclusive), calculated as weight in kg/height in m2
- Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
- Able to comply with the study procedures, in the opinion of the investigator.
- Able to give written consent for participation in the trial.
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to cetirizine or any other related drugs.
- Any disease or condition which might compromise the hemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Use of any medicine within 14 days prior to start of the study. In any such case subject selection will be at the discretion of the Principal investigator / Medical expert
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- A recent history of alcoholism (<2 years) or of moderate (180 mL/day) alcohol use, or consumption of alcohol within 48 hr prior to receiving IP.
- Smokers, who smoke more than 10 cigarettes / day or inability to abstain from smoking during the study.
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- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- History of psychiatric disorders.
- A history of difficulty in donating blood.
- Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of IP.
- Note: In case, the blood loss was ≤200 mL; subject can be dosed 60 days after the blood donation.
- A positive hepatitis screen including hepatitis B surface antigen, Anti- HCV and Anti HAV antibodies.
- A positive test result for HIV antibody and/or syphilis.
- The receipt of an investigational drug or product, or participation in a drug research study within a period of 90 days prior to the first dose of IP (Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study).
- Note: If subject had participated in a study in which blood loss was ≤200 mL, subject can be dosed after completion of 60 days after the last sample of the previous study.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the IP and throughout the subjects participation in the study. In any such case subject selection will be at the discretion of the Principal lnvestigator/Medical expert.
About this study
Official title: Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg in Healthy Adult Human Male Subjects Under Fasting Conditions.
A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys laboratories with Zyrtec 10 mg of Pfizer labs in Healthy Adult Human Male Subjects Under Fasting Conditions.
Read the detailed description
Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Cross Over, and Comparative Oral Bioavailability study in healthy, adult, human, male subjects under Fasting Conditions.
- Conditions
- Healthy
- Being tested
- Cetirizine Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetirizine HydrochlorideDrug
Also called Zyrtec Tablets 10 mg
Cetirizine Hydrochloride Tablets 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Cetirizine | Experimental | Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys Laboratories Limited Receives: Drug: Cetirizine Hydrochloride |
| Zyrtec | Active comparator | Zyrtec Tablets 10 mg of Pfizer Labs Receives: Drug: Cetirizine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bio-equivalence study of Dr Reddys Laboratories Cetirizine Hydrochloride Tablets 10 mg
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startJan 2006
- Primary completionJan 2006
- Study completionFeb 2006
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charu Gautam, MD, Principal investigator, Lambda Therapeutic Research Ltd, Ahmedabad - 380 054, Gujarat, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064102
- Sponsor's protocol ID
- 007-06
- Status last verified
- Feb 2010
- First submitted
- 4 Feb 2010
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg in Healthy Adult Human Male Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01064102
- Acronym / sponsor ID
- 007-06
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jan 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 8 Feb 2010 (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.
A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys laboratories with Zyrtec 10 mg of Pfizer labs in Healthy Adult Human Male Subjects Under Fasting Conditions.
Detailed description
Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Cross Over, and Comparative Oral Bioavailability study in healthy, adult, human, male subjects under Fasting Conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetirizine | Experimental | Drug: Cetirizine HydrochlorideCetirizine Hydrochloride Tablets 10 mg of Dr. Reddys Laboratories Limited |
| Zyrtec | Active comparator | Drug: Cetirizine HydrochlorideZyrtec Tablets 10 mg of Pfizer Labs |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
- Having a Body Mass Index (BMI) between 18.5 and 24.9 {both inclusive), calculated as weight in kg/height in m2
- Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
- Able to comply with the study procedures, in the opinion of the investigator.
- Able to give written consent for participation in the trial.
Key exclusion criteria (17 listed)
- Known hypersensitivity or idiosyncratic reaction to cetirizine or any other related drugs.
- Any disease or condition which might compromise the hemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Use of any medicine within 14 days prior to start of the study. In any such case subject selection will be at the discretion of the Principal investigator / Medical expert
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- A recent history of alcoholism (<2 years) or of moderate (180 mL/day) alcohol use, or consumption of alcohol within 48 hr prior to receiving IP.
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 HydrochlorideAlso: Zyrtec Tablets 10 mgCetirizine Hydrochloride Tablets 10 mg | Drug | Cetirizine, Zyrtec |
Primary outcome
Bio-equivalence study of Dr Reddys Laboratories Cetirizine Hydrochloride Tablets 10 mg
Time frame: 2 months
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 8 Feb 2010.
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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.
Charu Gautam, MD principal investigator
Lambda Therapeutic Research Ltd, Ahmedabad - 380 054, Gujarat, INDIA
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cetirizine Hydrochloride in people with Healthy, run by Dr. Reddy's Laboratories Limited.
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 5 inclusion and 17 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 8 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bio-equivalence study of Dr Reddys Laboratories Cetirizine Hydrochloride Tablets 10 mg (time frame: 2 months). 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 8 Feb 2010.