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Primary Objective: To evaluate the pharmacokinetics and bioequivalence of the test products 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: 18 mcg, manufactured by Boehringer Ingelheim Pharma GmbH and CO.KG) by oral inhalation in healthy participants under fasting conditions.
Secondary Objective: To assess the safety of the test products Tiotropium Bromide Inhalation Powder (Strength: 18 mcg) and reference products Tiotropium Bromide Inhalation Powder (Spiriva®Handihaler®, Strength: 18 mcg) in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium Bromide Inhalation Powder | Experimental | Test Product Tiotropium Bromide Inhalation Powder (Strength: 18 microgram (mcg), as tiotropium, equivalent to 22.5 microgram of tiotropium bromide monohydrate). The subjects randomly received single oral dose of tiotropium bromide inhaling powder |
|
| Spiriva®Handihaler® | Experimental | Reference Product (Spiriva®Handihaler®, Strength: 18 microgram, as tiotropium, equivalent to 22.5 microgram of tiotropium bromide monohydrate). The subjects randomly received single oral dose of Spiriva®Handihaler® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium Bromide Inhalation Powder | Drug | By binding to M3 receptors, the action of acetylcholine is blocked to relieve spasm of bronchial smooth muscle. |
|
| 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 minuets, 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 minuets, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168, 216 hours post-dose |
| Area under the plasma concentration versus time curve (AUC) 0 - infinity | 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 minuets, 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 minuets, 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 |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Bengbu | Anhui | 233000 | China |
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| Spiriva®Handihaler® | Drug | By binding to M3 receptors, the action of acetylcholine is blocked 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 minuets, 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 minuets, 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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