Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
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/metformin(high dose) (Drug); Linagliptin/metformin(low dose) (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 aim of the trial is to assess the relative bioavailability of fixed dose combination
tablets of linagliptin and metformin compared to the administration of two single tablets
(linagliptin and metformin ) in Chinese subjects. The availability of a fixed dose
combination tablet is expected to significantly enhance patients` compliance with
antidiabetic treatment., in particular with concern to the frequent polypharmacy in diabetic
patients.
Clinical Details
Official title: Characterisation of Fixed Dose Combination Tablets of Linagliptin 2.5 mg/Metformin 850 mg or Linagliptin 2.5 mg/Metformin 500 mg and Relative Oral Bioavailability Compared With Single Linagliptin 2.5 mg and Metformin 850 mg or 500 mg Tablets Administered Together to Healthy Chinese Male and Female Volunteers in an Open Label, Randomised, Single-dose, Two-way Crossover, Phase I Study
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 0 to 72 Hours (AUC0-72)Maximum Measured Concentration (Cmax) of Linagliptin. Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval 0 to the Last Quantifiable Concentration (AUC0-tz) Maximum Measured Concentration (Cmax) of Metformin
Secondary outcome: Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) for LinagliptinAUC(0-infinity) for Metformin AUC0-tz for Linagliptin
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
1. Healthy male and female subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
Locations and Contacts
1288.5.86001 Boehringer Ingelheim Investigational Site, Beijing, China
Additional Information
Starting date: February 2012
Last updated: June 6, 2013
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