CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
Empagliflozin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age 18 to 55 years
  • ✓BMI 18.5 to 29.9 kg/m²
  • ✓Healthy status based on complete medical history, physical examination, vital signs, ECG, and clinical laboratory tests
  • ✓Adequate contraception for female subjects starting 30 days before first dose through 30 days after completion
Key exclusion· 6
  • ✕Any clinically relevant abnormality in medical examination, BP, PR, or ECG
  • ✕Systolic BP outside 90-140 mmHg, diastolic BP outside 50-90 mmHg, or pulse rate outside 45-90 bpm on repeated measurement
  • ✕Laboratory values outside reference range considered clinically relevant
  • ✕Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02758171
NCT02758171Phase 1Completed
CompareCT.gov

Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Linagliptin Compared With the Free Combination of Empagliflozin Tablet and Linagliptin Tablet in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Crossover Study)

Boehringer Ingelheim·interventional·Posted May 2, 2016·Updated Nov 22, 2017

In Brief

A Phase 1 clinical trial evaluating Empagliflozin and Linagliptin for Healthy. Completed, enrolled 56 participants across 1 site.

Detailed Summary

The primary objective of this trial is to investigate the bioequivalence of one fixed dose combination tablet of empagliflozin/linagliptin (Test, T) compared with the free combination of one empagliflozin tablet and one linagliptin tablet (Reference, R) administered as single dose under fasted conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
CollaboratorsEli Lilly and Company

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2, 2016
Enrollment StartMay 17, 2016
Primary CompletionJul 29, 2016
Study CompletionAug 3, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.2 years ago

Interventions

Empagliflozindrug

Linagliptindrug