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
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