drugset / Trial / NCT04422028

Bioavailability of Desogestrel 0.075 mg Tablets With Regards to Reference Product

NCT04422028

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

Summary

This Pivotal study investigated the bioavailability in women of 2 tablet formulations containing Desogestrel 0.075 mg. The Pivotal study was performed at a single site with 30 subjects. Participants took 2 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There was a washout of 14 days between each study period.

Timeline

Start
2020-01-11
Primary completion
2020-01-11
Completion
2020-01-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Desogestrel Small molecule 0.075 mg

Indications

No indication recorded.