Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions
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ClinicalTrials.gov Identifier: NCT00865618 |
Recruitment Status :
Completed
First Posted : March 19, 2009
Last Update Posted : March 29, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA Drug: Inspra 50 mg Tablets GD Searle LLC, USA | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparative Bioavailability Study of Eplerenone 50 mg Tablets (Sandoz Inc., USA) and Inspra 50 mg Tablets (GD Searle LLC, USA) in Healthy Male and/or Female Volunteers Under Fed Conditions. |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | July 2006 |
Actual Study Completion Date : | July 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Eplerenone 50mg Tablets
|
Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA |
Active Comparator: 2
INSPRA 50mg Tablets
|
Drug: Inspra 50 mg Tablets GD Searle LLC, USA |
- Bioequivalence according to US FDA guidelines [ Time Frame: 10 days ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865618
Principal Investigator: | Deepen Patel, M.D., CCFP | Allied Research International Inc. |
Responsible Party: | Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. |
ClinicalTrials.gov Identifier: | NCT00865618 |
Other Study ID Numbers: |
P1DX06003 |
First Posted: | March 19, 2009 Key Record Dates |
Last Update Posted: | March 29, 2017 |
Last Verified: | March 2009 |
Hypertension Malnutrition Vascular Diseases Cardiovascular Diseases Nutrition Disorders Eplerenone Mineralocorticoid Receptor Antagonists |
Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents Antihypertensive Agents |