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| ID | Type | Description | Link |
|---|---|---|---|
| MIZOALY1001 | Other Identifier | Xian-Janssen Pharmaceutical Ltd., China |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of volunteers with adverse events as a measure of safety and tolerability | Up to Day 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd., China Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
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| ID | Term |
|---|---|
| C076170 | mizolastine |
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| Mizolastine (imported) | Drug | Healthy male volunteers will receive 10 mg imported mizolastine tablets on Day 1 and Day 8 |
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| 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) |