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Explore the influence of different administration methods (titration/non-titration) of Hemay005 tablets on the incidence of adverse reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0-45mg Hemay005 | Active Comparator | By using titration method, the dosage of the drug was gradually increased from 0 to 45 mg BID for 14 days |
|
| 45mg Hemay005 | Active Comparator | The subjects took the medicine twice a day, 45 mg each time, for 14 days. |
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| 0-60mg Hemay005 | Active Comparator | By using titration method, the dosage of the drug was gradually increased from 0 to 60 mg BID for 14 days |
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| 60mg Hemay005 | Active Comparator | The subjects took the medicine twice a day, 60 mg each time, for 14 days. |
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| 0-75 mg Hemay005 | Active Comparator | By using titration method, the dosage of the drug was gradually increased from 0 to 75 mg BID for 14 days |
|
| 75 mg Hemay005 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemay005 tablet | Drug | Hemay005 is a small molecule PDE4 inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Explore the influence of different administration methods (titration/non-titration) of Hemay005 tablets on the incidence of adverse reactions. | Number of Participants With Treatment-Related Adverse Events as Assessed by Grade of Adverse Event | 14 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | 241000 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C000628605 | Hemay005 |
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The subjects took the medicine twice a day, 75 mg each time, for 14 days. |
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| placebo | Placebo Comparator | The subjects took the medicine twice a day. In the first week, they took placebos; in the second week, they took 60 mg hemay005 each time, for a total of 14 days of medication. |
|
| Placebo | Drug | Placebos are the same as drugs, but contain no Hemay005. |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |