Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.

Boehringer Ingelheim18 enrolled

Overview

Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

EmpagliflozinDRUG

high dose of empagliflozin after overnight fasting for at least 10 h

EmpagliflozinDRUG

low dose empagliflozin after overnight fasting for at least 10 h

EmpagliflozinDRUG

high dose of empagliflozin after a standardised high fat breakfast

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)

1245.79.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Outcomes

Primary Outcomes

Area Under the Curve 0 to Infinity (AUC0-∞)

Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 hours extrapolated to infinity (AUC0-∞). The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.

Time frame: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Maximum Measured Concentration (Cmax)

Maximum measured concentration of empagloflozin (empa) in plasma, per period. The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.

Time frame: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Secondary Outcomes

Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator.

Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.

Time frame: Screening until end of trial, average of 45 days

Data from ClinicalTrials.gov

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