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Clinical trial

Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Efez 50 mg Eplerenone Film-coated Tablets Versus INSPRA® 50 mg Eplerenone Film-coated Tablets, in Healthy Adult Male and Female Subjects Under Fasting Conditions

NCT05663372 is registered in ClinicalTrials.gov with Darnitsa Pharmaceutical Company as lead sponsor.

NCT NCT05663372
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Registry record

As filed in ClinicalTrials.gov.

Title
Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Efez 50 mg Eplerenone Film-coated Tablets Versus INSPRA® 50 mg Eplerenone Film-coated Tablets, in Healthy Adult Male and Female Subjects Under Fasting Conditions
Lead sponsor
Darnitsa Pharmaceutical Company
Phase
Phase 1
Overall status
Completed
Start date
December 7, 2021
Completion date
December 28, 2021
Enrollment
36 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

bioequivalence, healthy subjects