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drugset / Trial / NCT04230083

Bioavailability of Dienogest 2.0 mg With Regards to Reference Product

NCT04230083 ↗

Phase 1 Completed 30 enrolled Laboratorios Andromaco S.A.
RandomizedCrossoverOpen-labelBasic science

Summary

This Pivotal study will investigate the bioavailability in women of 1 tablet formulations containing Dienogest 2.0 mg. The Pivotal study will be performed at a single site with 30 subjects. Participants will take 1 tablet 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
2019-12-07
Primary completion
2019-12-10
Completion
2019-12-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Dienogest Small molecule 2 mg Oral

Indications

No indication recorded.