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Completed

NCT Number: NCT01276327

Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components

The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1264.14.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

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 + Pioglitazone

Drug

Medium doses, oral administration

Linagliptin/Pioglitazone

Drug

Medium dose oral administration

Primary outcomes

  1. AUC0-72 of Linagliptin

    Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours

  2. Cmax of Linagliptin

    Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

    Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.

  3. AUC0-tz of Pioglitazone

    Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point

  4. Cmax of Pioglitazone

    Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

    Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.

Secondary outcomes

  1. AUC0-tz for Linagliptin

    Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point for Linagliptin

  2. AUC0-∞ of Linagliptin

    Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin

  3. AUC0-∞ of Pioglitazone

    Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone

  4. Tmax for Linagliptin

    Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

    Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin

  5. Tmax for Pioglitazone

    Time frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

    Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin 5 mg / Pioglitazone 30 mg Compared With Its Mono-components in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Replicate Design Study With Two Treatments in Four Crossover Periods)

Important dates

Study start
2011
Primary completion
2011
First posted
Jan 13, 2011
Registry last updated
Jun 9, 2014

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.

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