FastingPhase 1NCT01506076
Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg of Dr. Reddy's Under Fasting Conditions
A Phase 1 study testing Levocetirizine DiHCl in people with Fasting, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance, under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Levocetirizine DiHCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2007to Jan 2008
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will provide written informed consent.
- Subjects must be healthy adults within 18-45 years of age (inclusive).
- Body mass index of ≥18.5 kg/m2 and ≤25 kg/m2, with body weight not less than 50 kg.
- Subjects must be of normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the dosing in Period-I.
- Have normal ECG, chest X-Ray and vital signs and clinically non significant changes in ECG \& chest X-Ray.
- Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
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- Subjects will be Non smokers or moderate smokers (less than 10 cigarettes a day) for at least 6 months.
- If subject is a female volunteer and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device(IUD), or abstinence.
- or is postmenopausal for at least 1 year. is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
- •Each female subject will be given a urine pregnancy test at screening, check-in for period-1, period-2 and post study.
Who cannot join
- Subjects incapable of understanding the informed consent.
- Subjects with BP lesser than 90/60 mm of Hg or BP greater than or equal to 140/90 mm of Hg.
- History of hypersensitivity or idiosyncratic reaction to Levocetirizine or other related drugs.
- Any evidence of impairment of renal, hepatic, gastro intestinal, lung and cardiac function.
- Subjects with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study.
- Regular smoker who smokes more than ten cigarettes daily or has difficulty in abstaining from smoking for the duration of each study period.
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- Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within the past two weeks prior to prior to dosing in Period-1.
- History of any psychiatric illness, which may impair the ability to provide written, informed consent.
- Subject is mentally or legally incapacitated, or has a history of significant psychiatric disorder.
- Subjects who have a history of alcohol or substance/ drug of abuse within the last 5 years.
- Subjects with clinically significant abnormal values of laboratory parameters, including positive results of HIV, HBV, HCV, RPR tests.
- Subjects who participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
- Subjects who are unable to or likely to be non-compliant with protocol requirements or restrictions.
- Subjects who are intolerant to venipuncture.
- Any subject in whom Levocetirizine Dihydrochloride is contraindicated for medical reasons.
- Female volunteers who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
- Female volunteers demonstrating a positive pregnancy screen.
- All female subjects will be screened for pregnancy at screening, check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
- Female volunteers who are currently breast feeding. Female subjects who are pregnant, breast-feeding or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate.
- Subjects with positive urine screen for drugs of abuse at the time of admission check-in for each period will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg With XYZAL® Tablets 5 mg in Healthy Subjects Under Fasting Conditions
The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance, under fasting conditions.
Read the detailed description
A pivotal study to compare the Bioequivalence of Levocetirizine DiHCl Tablets 5 mg of Dr.Reddy's Laboratories Limited with XYZAL® Tablets 5 mg of UCB Farchim S.A. in healthy, human subjects under fasting conditions.
- Conditions
- Fasting
- Being tested
- Levocetirizine DiHCl
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levocetirizine DiHClDrug
Also called XYZAL
Levocetirizine DiHCl Tablets 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Levocetirizine DiHCl Tablets, 5 mg | Experimental | Levocetirizine DiHCl Tablets, 5 mg of Dr. Reddy's Laboratories Ltd. Receives: Drug: Levocetirizine DiHCl |
| XYZAL | Active comparator | XYZAL Tablets 5 mg of UCB Farchim S.A. Receives: Drug: Levocetirizine DiHCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence is based on Cmax and AUC parameters
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startDec 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudershan Vishwanath, MD, Principal investigator, Vimta Labs Ltd.,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506076
- Sponsor's protocol ID
- 07446/07-08
- Status last verified
- Jan 2012
- First submitted
- 5 Jan 2012
- Last updated
- 9 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg With XYZAL® Tablets 5 mg in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01506076
- Acronym / sponsor ID
- 07446/07-08
- Conditions
- Fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 9 Jan 2012 (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.
The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance, under fasting conditions.
Detailed description
A pivotal study to compare the Bioequivalence of Levocetirizine DiHCl Tablets 5 mg of Dr.Reddy's Laboratories Limited with XYZAL® Tablets 5 mg of UCB Farchim S.A. in healthy, human 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 |
|---|---|---|
| Levocetirizine DiHCl Tablets, 5 mg | Experimental | Drug: Levocetirizine DiHClLevocetirizine DiHCl Tablets, 5 mg of Dr. Reddy's Laboratories Ltd. |
| XYZAL | Active comparator | Drug: Levocetirizine DiHClXYZAL Tablets 5 mg of UCB Farchim S.A. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects will provide written informed consent.
- Subjects must be healthy adults within 18-45 years of age (inclusive).
- Body mass index of ≥18.5 kg/m2 and ≤25 kg/m2, with body weight not less than 50 kg.
- Subjects must be of normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the dosing in Period-I.
- Have normal ECG, chest X-Ray and vital signs and clinically non significant changes in ECG \& chest X-Ray.
Key exclusion criteria (20 listed)
- Subjects incapable of understanding the informed consent.
- Subjects with BP lesser than 90/60 mm of Hg or BP greater than or equal to 140/90 mm of Hg.
- History of hypersensitivity or idiosyncratic reaction to Levocetirizine or other related drugs.
- Any evidence of impairment of renal, hepatic, gastro intestinal, lung and cardiac function.
- Subjects with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for 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 |
|---|---|---|
| Levocetirizine DiHClAlso: XYZALLevocetirizine DiHCl Tablets 5 mg | Drug | Levocetirizine DiHCl Tablets, 5 mg, XYZAL |
Primary outcome
Bioequivalence is based on Cmax and AUC parameters
Time frame: 2 month
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 9 Jan 2012.
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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.
Sudershan Vishwanath, MD principal investigator
Vimta Labs Ltd.,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levocetirizine DiHCl in people with Fasting, run by Dr. Reddy's Laboratories Limited at 1 site in India.
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 10 inclusion and 20 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 9 Jan 2012. 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 India. 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.
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?
Bioequivalence is based on Cmax and AUC parameters (time frame: 2 month). 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 9 Jan 2012.