drugset / Trial / NCT02697851

Pharmacokinetic Effect of Evotaz/Microgynon Co-administration

NCT02697851

RandomizedCrossoverOpen-labelHealth-services research

Summary

This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There will be two study arms, who will take the medications in different orders: GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56.

Timeline

Start
2016-07
Primary completion
2017-10-31
Completion
2017-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Evotaz® Unknown 150 mg
Subject Evotaz® Unknown 300 mg
Subject Microgynon 30® Unknown 30 ug Oral
Subject Microgynon 30® Unknown 150 ug Oral