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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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This trial was divided into two parts. The first part was the PK bioequivalence study in healthy people, which was designed as a single-dose, randomized, open, four-cycle, two-sequence, fully repeated crossover design, and planned to enroll 20 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test preparation:Methylcholine chloroacetate for inhalation | Experimental | Inhale methacholine solution for 1 minute |
|
| Reference preparation:Methylcholine chloroacetate for inhalation((Provocholin) | Active Comparator | Inhale methacholine solution for 1 minute |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test preparation:Methylcholine chloroacetate for inhalation | Drug | Cholinergic agonists |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Concentration | The highest plasma drug concentration that can be achieved after administration | Within 60 minutes before administration and within 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 6 hours, and 8 hours after administration |
| The area under the blood concentration time curve when the time is from 0 to the last time point selected(AUC0-t) | The area under the blood concentration time curve from 0 to t after administration | Within 60 minutes before administration and within 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 6 hours, and 8 hours after administration |
| The area under the blood concentration time curve during time from 0 to infinity(AUC0-∞) | Area under the blood concentration time curve after medication | Within 60 minutes before administration and within 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 6 hours, and 8 hours after administration |
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Inclusions Criteria
3) Normal pulmonary function test (FEV1 ≥ 80% predicted value, FEV1/FVC ≥ 0.7), FEV1 decline rate after inhalation of saline is no more than 20%, and methacholine chloride provocation test is negative.
4. Sign the informed consent form before the experiment and fully understand the content, process and possible adverse reactions of the experiment.
5. Subjects can communicate well with researchers and understand and comply with the requirements of this study.
Exclusions Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| Reference preparation:Methylcholine chloroacetate for inhalation((Provocholin) | Drug | Cholinergic agonists |
|