A Bioequivalence Study of Domestic (Made in China) and Imported Mizolastine Tablets in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bioequivalence Study of Home-made and Imported Mizolastine Tablets in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Mizolastine domestic (made in China)
* Drug: Mizolastine (imported)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>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. | Drug: Mizolastine domestic (made in China)<br>* Healthy male volunteers will receive 10 mg domestic (made in China) mizolastine tablets on Day 1 and Day 8<br>Drug: Mizolastine (imported)<br>* Healthy male volunteers will receive 10 mg imported mizolastine tablets on Day 1 and Day 8<br>|
| Experimental: Sequence B<br>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. | Drug: Mizolastine domestic (made in China)<br>* Healthy male volunteers will receive 10 mg domestic (made in China) mizolastine tablets on Day 1 and Day 8<br>Drug: Mizolastine (imported)<br>* Healthy male volunteers will receive 10 mg imported mizolastine tablets on Day 1 and Day 8<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mizolastine (imported): Maximum Observed Plasma Concentration (Cmax) | The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. | 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. | 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. | 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. | 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. | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of volunteers with adverse events as a measure of safety and tolerability |  | Up to Day 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imported, Healthy, Bioequivalence, Mizolastine, Domestic