Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam

PHASE1CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

November 29, 2017

Primary Completion Date

July 4, 2018

Study Completion Date

February 19, 2019

Conditions
Biological Availability
Interventions
DRUG

levonorgestrel/ Microlut

In Period 1, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 1, In Period 2, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 15 In Period 3, 0.03 mg single dose administered as 1x0.03 mg tablet at Study Day 26

DRUG

Norethindrone/ Noriday

In Period 1, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 1, In Period 2, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 15 In Period 3, 0.35 mg single dose administered as 1x0.35 mg tablet at Study Day 26

DRUG

Desogestrel/ Cerazette

In Period 1, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 1, In Period 2, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 15 In Period 3, 0.075 mg single dose administered as 1x0.075 mg tablet at Study Day 26

DRUG

Dienogest/ Visanne

In Period 1, 2 mg single dose administered as 1x2 mg tablet on Study Day 1, In Period 2, 2 mg single dose administered as 1x2 mg tablet on Study Day 15 In Period 3, 2 mg single dose administered as 1x2 mg tablet at Study Day 26

DRUG

Drospirenone, Ethinylestradiol/ Yasmin

In Period 1, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 1, In Period 2, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 15, In Period 3, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 26,

DRUG

Midazolam/ Midazolam-ratiopharm

In Period 1, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 1, In Period 2, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 15 In Period 3, 1 mg single dose administered as 1x0.5 ml oral solution at Study Day 26

DRUG

Rifampicin

In period 2, 10 mg (suspension, 0.5 ml) for 11 days at 10 mg/day In period 3, 600 mg (film-coated tablets) for 11 days at 600 mg/day

Trial Locations (2)

41061

CRS Clinical-Research-Services Mönchengladbach GmbH, Mönchengladbach

68167

CRS Clinical-Research-Services Mannheim GmbH, Mannheim

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY