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drugset / Trial / NCT05349396

Bioavailability of Eszopiclone 3.0 mg With Regards to Reference Product

NCT05349396 ↗

Phase 1 Completed 28 enrolled Laboratorios Andromaco S.A.
RandomizedCrossoverOpen-labelBasic science

Summary

This study will investigate the bioavailability in fasting healthy, adult, human subjects of 1 tablet of two formulations containing Eszopiclone 3mg. The study will be performed at a single site with 28 subjects. Participants will take 1 tablet of the test product 1, and 1 tablet of the test product 2, and reference product in 4 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 2 days between each study period.

Timeline

Start
2022-04-11
Primary completion
2022-04-19
Completion
2022-04-19

Drugs

EvaluationDrugModalityDoseRoute
Comparator Eszopiclone Small molecule 3 mg Oral

Indications

No indication recorded.