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Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets

NCT01845077 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-08-19

Study results available
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Summary

The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin \& metformin and the single tablets of linagliptin and metformin when administered singularly.

Conditions

  • Healthy

Interventions

DRUG

2x500 mg Metformin (Glumetza)

2 tablets

DRUG

5 mg Linagliptin/1000 mg Metformin FDC

FDC tablet

DRUG

5 mg Linagliptin (Tradjenta)

1 tablet

DRUG

5 mg Linagliptin (Tradjenta)

1 tablet

DRUG

3x500 mg Metformin (Glumetza)

3 tablets

DRUG

5 mg Linagliptin (Tradjenta)

1 tablet

DRUG

2 x 500 mg Metformin (Glumetza)

2 tablets

DRUG

5 mg Linagliptin/1000mg Metformin FDC

FDC Tablet

DRUG

2 x 2.5 mg Linagliptin/750 mg Metformin FDC

2 FDC tablets

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01845077 on ClinicalTrials.gov