Phase 1
Completed N=50
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets
Healthy
Source: ClinicalTrials.gov NCT02821910 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) — 5990; 6120; 6430; 6250 nanomoles (nmol)*hours (h)/litres (L)
Summary
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin & metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR administered simultaneously.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) |
5990; 6120; 6430; 6250; 2080; 2130 | — |
| PRIMARY Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) |
13900; 13900; 7920; 8260; 12000; 12200 | — |
| PRIMARY Maximum Measured Concentration of Empagliflozin in Plasma (Cmax) |
594; 630; 872; 817; 232; 235 | — |
| PRIMARY Maximum Measured Concentration of Metformin in Plasma (Cmax) |
1290; 1300; 1010; 1020; 1170; 1150 | — |
| PRIMARY Maximum Measured Concentration of Linagliptin in Plasma (Cmax) |
6.37; 6.51; 9.66; 8.35; 6.25; 6.15 | — |
| PRIMARY Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72) |
273; 282; 290; 276; 258; 260 | — |
| SECONDARY Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
6060; 6190; 6490; 6300; 2130; 2180 | — |
| SECONDARY Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
14100; 14100; 8260; 8600; 12200; 12400 | — |
| SECONDARY Area Under the Concentration-time Curve of the Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
465; 483; 477; 443; 424; 420 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
- Age of 18 to 55 years (incl.)
- BMI of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
- Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:
Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device Sexually abstinent A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment) Surgically sterilised (including hysterectomy) Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle-stimulating hormone above 40 U/L and estradiol below 30 ng/L is confirmatory)
Exclusion criteria
- Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02821910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.