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

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: 2021-02-27
Primary completion: 2021-02-27
Completion: 2021-03-16

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Duloxetine	Small molecule	60 mg	—

Indications

No indication recorded.