Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01328184
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of this study is to investigate the possible effect of multiple oral doses of 25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (Microgynon®).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Test Microgynon + BI 10773 multiple doses of Microgynon + BI 10773 Reference Ethinylestradiol multiple doses of Microgynon Reference levonorgestrel multiple doses of Microgynon Test Ethinylestradiol multiple doses of Microgynon + BI 10773 Test levonorgestrel multiple doses of Microgynon + BI 10773
- Primary Outcome Measures
Name Time Method Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.
Levonorgestrel: Maximum Measured Concentration (Cmax,ss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval τ.
Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval τ.
Ethinylestradiol: Maximum Measured Concentration (Cmax,ss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.
- Secondary Outcome Measures
Name Time Method Levonorgestrel: Apparent Clearance at Steady State (CL/Fss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Apparent clearance of levonorgestrel in the plasma at steady state after oral administration
Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state
Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Apparent volume of distribution during the terminal phase at steady state after oral administration
Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration
Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state
Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Apparent volume of distribution during the terminal phase at steady state after oral administration
Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Mean residence time of ethinylestradiol in the body at steady state after oral administration
Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Mean residence time of levonorgestrel in the body at steady state after oral administration
Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Terminal half-life of ethinylestradiol in plasma at steady state
Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Terminal rate constant of levonorgestrel in plasma at steady state
Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Terminal half-life of levonorgestrel in plasma at steady state
Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss) Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. Terminal rate constant of ethinylestradiol in plasma at steady state
Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests. Day 1 to day 17 Number of participants with clinically relevant abnormalities in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as adverse events.
Assessment of Tolerability Within Day 24 to Day 31 Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable.
Trial Locations
- Locations (1)
1245.41.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany