Phase 1 Completed N=74 Randomized Treatment

Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects

Healthy

Source: ClinicalTrials.gov NCT02121509 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2016

Primary outcomePrimary: Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72) — 298.982; 307.320; 257.932; 261.680 nmol*h/L — p=<0.0001

Summary

The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)	298.982; 307.320; 257.932; 261.680	<0.0001 sig
PRIMARY Maximum Measured Concentration of Linagliptin in Plasma (Cmax)	8.909; 9.464; 6.729; 7.181	0.0004 sig
PRIMARY Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	10414.62; 10626.51; 19434.46; 18727.47	0.0001 sig
PRIMARY Cmax of Metformin in Plasma	1245.262; 1308.777; 1526.907; 1739.311	0.0013 sig
SECONDARY Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)	499.020; 506.245; 430.765; 458.042	<0.0001 sig
SECONDARY AUC0-inf of Metformin in Plasma	10831.52; 11055.51; 19706.52; 19073.16	<0.0001 sig

Eligibility Criteria

Inclusion criteria

Healthy male or female subjects

Exclusion criteria

Any relevant deviation from healthy condition

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02121509). 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.