Phase 1
N=48
Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01540487 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72) — 248; 251; 266; 264 nmol*h/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- linagliptin/metformin(high dose) (Drug); Linagliptin/metformin(low dose) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72) |
248; 251; 266; 264 | — |
| PRIMARY Maximum Measured Concentration (Cmax) of Linagliptin. |
6.90; 6.81; 7.54; 6.77 | — |
| PRIMARY Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval 0 to the Last Quantifiable Concentration (AUC0-tz) |
11700; 12100; 8240; 8010 | — |
| PRIMARY Maximum Measured Concentration (Cmax) of Metformin |
1680; 1780; 1220; 1190 | — |
| SECONDARY Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) for Linagliptin |
471; 433; 483; 541 | — |
| SECONDARY AUC(0-infinity) for Metformin |
12200; 12500; 8440; 8210 | — |
| SECONDARY AUC0-tz for Linagliptin |
248; 251; 266; 264 | — |
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.
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01540487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.