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The goal of this clinical trial is to Evaluate the Bioequivalence of Spironolactone Tablets 100mg (by SPH Sine Pharmaceutical Laboratories Co.,Ltd) and ALDACTONE® tablets 100mg (by GD SEARLE LLC) in Chinese Healthy Adult Volunteers under Fasting and Fed Conditions. It will also learn about the safety of the two drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | Spironolactone Tablets, 100 mg/tablet, to be orally administered. |
|
| Reference product | Active Comparator | ALDACTONE® Tablets,100 mg/tablet, to be orally administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone Tablets (Test) | Drug | Take one test tablet each period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Observed Concentration in Plasma | up to 24 hours after tablet intake |
| AUC 0-t | Area Under the Concentration-time Curve From Time Zero to Time of Last | up to 24 hours after tablet intake |
| AUC 0-∞ | Area Under the Concentration-time Curve From Time Zero to Infinity | up to 24 hours after tablet intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Spironolactone Tablets (Reference) |
| Drug |
Take one reference tablet each period |
|
|
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |