drugset / Trial / NCT04723238

Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions

NCT04723238

Phase 1 Completed 36 enrolled Laboratorios Andromaco S.A.
RandomizedCrossoverOpen-labelBasic science

Summary

This Study will investigate the bioavailability in fasting subjects of 1 capsule formulation containing Duloxetine 60 mg. The Study will be performed at a single site with 36 subjects. Participants will take 1 capsule of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 14 days between each study period.

Timeline

Start
2021-01-23
Primary completion
2021-02-09
Completion
2021-03-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Duloxetine Small molecule 60 mg

Indications

No indication recorded.