Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

Phase 1CompletedNCT01581931

Boehringer Ingelheim32 enrolled

Overview

To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Linagliptin/metforminDRUG

FDC

MetforminDRUG

single tablet Metformin

LinagliptinDRUG

single tablet Linagliptin

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)

1288.20.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Outcomes

Primary Outcomes

Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin

AUC0-tz represents the area under the concentration curve of metformin in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. Note, the geometric mean is actually an adjusted geometric mean.