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Primary Objective: To evaluate the pharmacokinetics of Tiotropium Bromide Inhalation Powder (Strength:18 mcg; manufactured by Chia Tai Tianqing Pharmaceutical Group Co. Ltd) and reference products Tiotropium Bromide Inhalation Powder (Spiriva®, Handihaler®, Strength: 18mcg, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc) by oral inhalation of single dose in healthy participants under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product Tiotropium Bromide Inhalation Powder (Strength: 18 mcg) | Experimental | The subjects randomly received single oral inhalation dose of Tiotropium bromide inhaling powder generic product. |
|
| Reference Product (Spiriva®Handihaler®, Strength: 18 mcg) | Active Comparator | The subjects randomly received single oral inhalation dose of the reference listed drug (RLD) Spiriva®Handihaler®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium Bromide Inhalation Powder | Drug | It's a generic product of Spiriva HandiHaler. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Maximum plasma drug concentration | Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose |
| Area under the plasma concentration versus time curve (AUC) 0-t | plasma concentration-time curve from zero to the time of the last measurable time point t. | Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose |
| Area under the plasma concentration versus time curve (AUC) 0-∞ | area under the plasma concentration-time curve from zero to infinity | Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| The time to maximum plasma concentration (Tmax) | The time to maximum plasma concentration (observed) | Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose |
| The elimination half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan (Zhengzhou) Zhonghui Cardiovascular Hospital | Zhengzhou | Henan | 450003 | China |
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| Spiriva HandiHaler | Drug | Tiotropium Bromide Inhalation Powder RLD, which binds to M3 receptors, and blocks the action of acetylcholine to relieve spasm of bronchial smooth muscle. |
|
Elimination half-life of plasma concentration |
| Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose |
| Terminal elimination rate constant (Kel) | Terminal elimination rate constant | Pre-dose and 1 2, 3, 4, 5 6, 7, 8, 10, 15, 20, 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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