drugset / Trial / NCT04713904

Bioavailability of Clormadinone/Ethinyl Estradiol Tablets 2 mg/0.02 mg With Regards to Reference Product

NCT04713904

Phase 1 Completed 38 enrolled Laboratorios Andromaco S.A.
RandomizedCrossoverOpen-labelBasic science

Summary

The study will be performed at a single site with 38 subjects. Participantswill take 2 tablets 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
2021-01-16
Primary completion
2021-01-16
Completion
2021-02-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clormadinone Unknown 2 mg
Comparator ethinyl estradiol Small molecule 0.02 mg

Indications

No indication recorded.