Relative Bioavailability of Empagliflozin (BI 10773) and Ramipril Administered Together Compared to Empagliflozin (BI 10773) and Ramipril Alone in Healthy Volunteers

Boehringer Ingelheim23 enrolled

Overview

Primary objective:To investigate if BI 10773 affects the pharmacokinetics of ramipril and if ramipril affects the pharmacokinetics of BI 10773.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

BI 10773DRUG

medium dose, oral administration

RamiprilDRUG

Medium dose oral administration on day 2-5

BI 10773DRUG

medium dose oral administration

Ramipril

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1\. healthy male and female subjects Exclusion criteria: 1\. Any relevant deviation from healthy conditions.

Locations (1)

1245.45.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Outcomes

Primary Outcomes

Total Empa: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss)

Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of empagliflozin (empa).

Time frame: 0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4

Total Empa: Maximum Measured Concentration (Cmax,ss)

Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of empagliflozin (empa).

Total Ramipril: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss).

Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of ramipril.

Total Ramipril: Maximum Measured Concentration (Cmax,ss)

Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of ramipril.

Total Ramiprilat: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss).

Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of ramiprilat (active metabolite of ramipril).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Empa: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N)

Predose concentration of the analyte in plasma prior to administration of the Nth dose, of empagliflozin.

Ramiprilat: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N)

Predose concentration of the analyte in plasma prior to administration of the Nth dose, of ramiprilat. Note, predose concentrations for ramipril were all below the limit of quantification (BLQ) and therefore the predose concentration of the analyte in plasma prior to administration of the Nth dose, of ramipril was not analysed.

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

Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state.

Terminal Rate Constant (λz,ss)

Terminal rate constant in plasma at steady-state

Terminal Half-life (T 1/2,ss)

Terminal half-life of the analyte in plasma at steady-state.

Mean Residence Time (MRTpo,ss)

Mean residence time of the analyte in the body after oral administration at steady-state.

Apparent Clearance After Extravascular Administration (CL/Fss)

Apparent clearance of the analyte in plasma after extravascular administration at steady-state.

Apparent Volume of Distribution During the Terminal Phase (Vz/Fss)

Apparent volume of distribution at steady-state during the terminal phase λz following an extravascular dose.

Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Tolerability

Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.

Time frame: From drug administration until end of washout period (36 days)