Skip to main content
OpenTrials
Completed

NCT Number: NCT01540487

Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1288.5.86001 Boehringer Ingelheim Investigational Site

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female subjects

Exclusion criteria

  • Any relevant deviation from healthy conditions

Treatment and study plan

linagliptin/metformin(high dose)

Drug

patient would take fixed dose combination tablets of linagliptin /metformin (high dose) and single linagliptin and metformin (High dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.

Linagliptin/metformin(low dose)

Drug

patient would take fixed dose combination tablets of linagliptin /metformin (low dose) and single linagliptin and metformin (Low dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.

Primary outcomes

  1. Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72)

    Time frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.

  2. Maximum Measured Concentration (Cmax) of Linagliptin.

    Time frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.

  3. Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval 0 to the Last Quantifiable Concentration (AUC0-tz)

    Time frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.

  4. Maximum Measured Concentration (Cmax) of Metformin

    Time frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.

Secondary outcomes

  1. Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) for Linagliptin

    Time frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.

    AUC0-infinity is based on predicted last concentration values.

  2. AUC(0-infinity) for Metformin

    Time frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.

    AUC0-infinity is based on predicted last concentration values.

  3. AUC0-tz for Linagliptin

    Time frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 28, 2012
Registry last updated
Aug 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.