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Objective is to investigate pharmacokinetics and to estimate the level of dose linearity of spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone from Spironolactone 25 mg, 50 mg and 100 mg Tablets
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Order of strenghts; 25 mg, 50 mg, 100 mg | Experimental |
| |
| Order of strenghts; 50 mg, 100 mg, 25 mg | Experimental |
| |
| Order of strenghts; 100 mg, 25 mg, 50 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | single dose of one tablet; 25 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, AUC0-t and AUC0-inf of Spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone in plasma | up to 72 h after the study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suhas Khandave, MD | Accutest Research Laboratories (I) Pvt. Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accutest Research Laboratories (I) Pvt. Ltd. | Mumbai | 400709 | India |
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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 | Drug | single dose of one tablet; 50 mg tablet |
|
| Spironolactone | Drug | single dose of one tablet; 100 mg tablet |
|
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |