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Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: levonorgestrel (Drug); levonorgestrel (Drug); Ethinylestradiol (Drug); Microgynon + BI 10773 (Drug); Ethinylestradiol (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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).

Clinical Details

Official title: An Open-label, Two-period, Fixed-sequence Trial to Evaluate the Effect of Multiple Doses of BI 10773 on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)

Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)

Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)

Levonorgestrel: Maximum Measured Concentration (Cmax,ss)

Secondary outcome:

Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)

Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)

Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss)

Levonorgestrel: Apparent Clearance at Steady State (CL/Fss)

Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)

Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)

Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss)

Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss)

Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss)

Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss)

Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss)

Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss)

Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests.

Assessment of Tolerability

Eligibility

Minimum age: 18 Years. Maximum age: 39 Years. Gender(s): Female.

Criteria:

Inclusion criteria: 1. Healthy female subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

Locations and Contacts

1245.41.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
Additional Information

Starting date: April 2011
Last updated: May 16, 2014

Page last updated: August 23, 2015

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