HealthyPhase 1NCT01928316
A Bioequivalence Study of Domestic (Made in China) and Imported Mizolastine Tablets in Healthy Volunteers
A Phase 1 study testing Mizolastine domestic (made in China) and Mizolastine (imported) in people with Healthy, run by Xian-Janssen Pharmaceutical Ltd..
Trial summary
The purpose of the study is to evaluate the bioequivalence (the way in which different forms of the same drug are absorbed in the body) of single-dose administration of domestic (made in China) mizolastine tablets and imported mizolastine tablets given at the same dose in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mizolastine domestic (made in China) and Mizolastine (imported)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jun 2009
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No history of smoking
- Body mass index between 18 and 28 kilogram per square meter
- Health status considered good by the investigator according to physical examination, medical history, vital signs, electrocardiogram and clinical laboratory results
- Must be able to read and understand the informed consent form and sign the informed consent form before carrying out any operation related to the study
Who cannot join
- Health examination does not comply with the inclusion criteria
- Serious alcohol abuse
- Known allergy to active ingredients or excipients
- Habitual use of any drug including Chinese medicine
About this study
Official title: Bioequivalence Study of Home-made and Imported Mizolastine Tablets in Healthy Volunteers
The purpose of the study is to evaluate the bioequivalence (the way in which different forms of the same drug are absorbed in the body) of single-dose administration of domestic (made in China) mizolastine tablets and imported mizolastine tablets given at the same dose in healthy volunteers
Read the detailed description
This is a single-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), crossover (method used to switch patients from one treatment arm to another in a clinical study) study. Approximately, 24 healthy volunteers will be enrolled in the study. Eligible volunteers will be randomly allocated to either Sequence A group or Sequence B group. On Day 1, volunteers from Sequence A group will receive imported mizolastine tablets and volunteers from Sequence B group will receive domestic mizolastine tablets. There will be a washout period (no treatment) of 7 Days. On Day 8, the two sequence groups will be switched. Volunteers from Sequence A group will receive domestic mizolastine and volunteers from Sequence B group will receive imported mizolastine tablets. Safety evaluations will include assessments of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination, which will be measured throughout the study. The maximum study duration for each volunteer will be approximately 16 days.
- Conditions
- Healthy
- Being tested
- Mizolastine domestic (made in China), Mizolastine (imported)
- Keywords
- Healthy, Bioequivalence, Mizolastine, Domestic, Imported
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mizolastine domestic (made in China)Drug
Healthy male volunteers will receive 10 mg domestic (made in China) mizolastine tablets on Day 1 and Day 8
Mizolastine (imported)Drug
Healthy male volunteers will receive 10 mg imported mizolastine tablets on Day 1 and Day 8
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Healthy male volunteers will receive single oral dose of 10 mg imported mizolastine tablet on Day 1 and single oral dose of 10 mg domestic (made in China) mizolastine tablet on Day 8. Receives: Drug: Mizolastine domestic (made in China); Drug: Mizolastine (imported) |
| Sequence B | Experimental | Healthy male volunteers will receive single oral dose of 10 mg domestic (made in China) mizolastine tablet on Day 1 and single oral dose of 10 mg imported mizolastine tablet on Day 8. Receives: Drug: Mizolastine domestic (made in China); Drug: Mizolastine (imported) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mizolastine (imported): Maximum Observed Plasma Concentration (Cmax)
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Measured: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
Mizolastine (domestic [made in China]): Maximum Observed Plasma Concentration (Cmax)
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Measured: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
Mizolastine (imported): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Measured: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
Mizolastine (domestic [made in China]): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Measured: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
Mizolastine (imported): Time to Reach Maximum Observed Plasma Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
Mizolastine (domestic [made in China]): Time to Reach Maximum Observed Plasma Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
Secondary outcomes (1)
Number of volunteers with adverse events as a measure of safety and tolerability
Measured: Up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startJun 2009
- Primary completionJun 2009
- Study completionJun 2009
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xian-Janssen Pharmaceutical Ltd., China Clinical Trial, Study director, Xian-Janssen Pharmaceutical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928316
- Sponsor's protocol ID
- CR017872
- Other IDs
- MIZOALY1001
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2013
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Home-made and Imported Mizolastine Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01928316
- Acronym / sponsor ID
- CR017872
- Conditions
- Healthy
- Keywords
- Healthy, Bioequivalence, Mizolastine, Domestic, Imported
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Aug 2013 (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 the study is to evaluate the bioequivalence (the way in which different forms of the same drug are absorbed in the body) of single-dose administration of domestic (made in China) mizolastine tablets and imported mizolastine tablets given at the same dose in healthy volunteers
Detailed description
This is a single-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), crossover (method used to switch patients from one treatment arm to another in a clinical study) study. Approximately, 24 healthy volunteers will be enrolled in the study. Eligible volunteers will be randomly allocated to either Sequence A group or Sequence B group. On Day 1, volunteers from Sequence A group will receive imported mizolastine tablets and volunteers from Sequence B group will receive domestic mizolastine tablets. There will be a washout period (no treatment) of 7 Days. On Day 8, the two sequence groups will be switched. Volunteers from Sequence A group will receive domestic mizolastine and volunteers from Sequence B group will receive imported mizolastine tablets. Safety evaluations will include assessments of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination, which will be measured throughout the study. The maximum study duration for each volunteer will be approximately 16 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Mizolastine domestic (made in China), Drug: Mizolastine (imported)Healthy male volunteers will receive single oral dose of 10 mg imported mizolastine tablet on Day 1 and single oral dose of 10 mg domestic (made in China) mizolastine tablet on Day 8. |
| Sequence B | Experimental | Drug: Mizolastine domestic (made in China), Drug: Mizolastine (imported)Healthy male volunteers will receive single oral dose of 10 mg domestic (made in China) mizolastine tablet on Day 1 and single oral dose of 10 mg imported mizolastine tablet on Day 8. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- No history of smoking
- Body mass index between 18 and 28 kilogram per square meter
- Health status considered good by the investigator according to physical examination, medical history, vital signs, electrocardiogram and clinical laboratory results
- Must be able to read and understand the informed consent form and sign the informed consent form before carrying out any operation related to the study
Key exclusion criteria (4 listed)
- Health examination does not comply with the inclusion criteria
- Serious alcohol abuse
- Known allergy to active ingredients or excipients
- Habitual use of any drug including Chinese medicine
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 |
|---|---|---|
| Mizolastine domestic (made in China)Healthy male volunteers will receive 10 mg domestic (made in China) mizolastine tablets on Day 1 and Day 8 | Drug | Sequence A, Sequence B |
| Mizolastine (imported)Healthy male volunteers will receive 10 mg imported mizolastine tablets on Day 1 and Day 8 | Drug | Sequence A, Sequence B |
Primary outcome
Mizolastine (imported): Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Mizolastine (domestic [made in China]): Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Mizolastine (imported): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Mizolastine (domestic [made in China]): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Mizolastine (imported): Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Mizolastine (domestic [made in China]): Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
1 secondary outcome
Number of volunteers with adverse events as a measure of safety and tolerability
Time frame: Up to Day 16
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 23 Aug 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.
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial study director
Xian-Janssen Pharmaceutical Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mizolastine domestic (made in China) and Mizolastine (imported) in people with Healthy, run by Xian-Janssen Pharmaceutical Ltd..
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 4 inclusion and 4 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 23 Aug 2013. 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?
Mizolastine (imported): Maximum Observed Plasma Concentration (Cmax) (time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)). The study lists 6 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 23 Aug 2013.