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Bioequivalence of a Medium, Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release in Healthy Subjects.

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Linagliptin (Drug); Metformin (Drug); Linagliptin/Metformin FDC (Drug); Linagliptin/Metformin FDC (Drug); Linagliptin/Metformin FDC (Drug); Linagliptin (Drug); Metformin (Drug); Metformin (Drug); Linagliptin/Metformin FDC (Drug); Linagliptin (Drug); Metformin (Drug); Linagliptin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

Clinical Details

Official title: Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release (2.5 mg/1000 mg) Compared With the Free Combination of Linagliptin and Metformin Extended Release Tablets in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Trial)

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72)

Maximum measured concentration of linagliptin in plasma (Cmax)

Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

Cmax of metformin in plasma

Secondary outcome:

Area under the concentration-time curve of linagliptin and metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)

AUC0-inf of metformin in plasma

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Healthy male or female subjects

Exclusion criteria:

- Any relevant deviation from healthy condition

Locations and Contacts

1288.11.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
Additional Information

Starting date: April 2014
Last updated: July 23, 2014

Page last updated: August 23, 2015

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