HealthyPhase 1MOLZNCT01491503
A Drug Interaction Study of Montelukast and Levocetirizine
A Phase 1 study testing Levocetirizine, montelukast sodium and Montelukast & levocetirizine in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men only
- Conditions the study is for
- Healthy
- What is being tested?
- Levocetirizine, montelukast sodium and Montelukast & levocetirizine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Jan 2012
- 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 20 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy male
- Age between 20 and 55
- Signed informed consent
Who cannot join
- Has a history of hypersensitivity to IP ingredients
- Hypotension or hypertension
- Has a history of acute infection within 14days of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized, 6-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Montelukast Sodium and Levocetirizine Dihydrochloride in Health Male Volunteers
The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- Levocetirizine, montelukast sodium, Montelukast & levocetirizine
- Keywords
- montelukast, levocetirizine, interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocetirizineDrug
Levocetirizine dihydrochloride 5mg. PO. Single dose.
montelukast sodiumDrug
Montelukast sodium 10mg. PO. Single dose.
Montelukast & levocetirizineDrug
Montelukast sodium 10mg \& levocetirizine dihydrochloride 5mg PO. Single dose.
| Study group | Role | What they receive |
|---|---|---|
| Montelukast and levocetirizine | Experimental | Not described Receives: Drug: Montelukast & levocetirizine |
| Montelukast | Active comparator | Not described Receives: Drug: montelukast sodium |
| Levocetirizine | Active comparator | Not described Receives: Drug: Levocetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
Measured: 0-36hrs
Cmax
Measured: 0-36hrs
Secondary outcomes (3)
Tmax
Measured: 0-36hrs
T1/2
Measured: 0-36hrs
AUCinf
Measured: 0-36hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionJan 2012
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.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wooseong Huh, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491503
- Sponsor's protocol ID
- HM-MOLZ-101
- Acronym
- MOLZ
- Status last verified
- Apr 2013
- First submitted
- 14 Oct 2011
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, 6-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Montelukast Sodium and Levocetirizine Dihydrochloride in Health Male Volunteers
- ClinicalTrials.gov ID
- NCT01491503
- Acronym / sponsor ID
- MOLZ / HM-MOLZ-101
- Conditions
- Healthy
- Keywords
- montelukast, levocetirizine, interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Dec 2011 (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 evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Montelukast and levocetirizine | Experimental | Drug: Montelukast & levocetirizine |
| Montelukast | Active comparator | Drug: montelukast sodium |
| Levocetirizine | Active comparator | Drug: Levocetirizine |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male
- Age between 20 and 55
- Signed informed consent
Key exclusion criteria (3 listed)
- Has a history of hypersensitivity to IP ingredients
- Hypotension or hypertension
- Has a history of acute infection within 14days of screening
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 |
|---|---|---|
| LevocetirizineLevocetirizine dihydrochloride 5mg. PO. Single dose. | Drug | Levocetirizine |
| montelukast sodiumMontelukast sodium 10mg. PO. Single dose. | Drug | Montelukast |
| Montelukast & levocetirizineMontelukast sodium 10mg \& levocetirizine dihydrochloride 5mg PO. Single dose. | Drug | Montelukast and levocetirizine |
Primary outcome
AUClast
Time frame: 0-36hrs
Cmax
Time frame: 0-36hrs
3 secondary outcomes
Tmax
Time frame: 0-36hrs
T1/2
Time frame: 0-36hrs
AUCinf
Time frame: 0-36hrs
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 5 Apr 2013.
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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.
Wooseong Huh, MD principal investigator
Samsung Medical Center
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, montelukast sodium and Montelukast & levocetirizine in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
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 3 inclusion and 3 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 5 Apr 2013. 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 South Korea. 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?
AUClast (time frame: 0-36hrs). The study lists 2 primary outcomes in all. 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 5 Apr 2013.