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Completed

NCT Number: NCT01242176

Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers

The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).

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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

1245.51.1 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

Treatment and study plan

BI 10773 XX (Trial Formulation 2)

Drug

one single dose tablet in the morning

BI 10773 (Final Formulation)

Drug

one single film-coated tablet in the morning

Primary outcomes

  1. Area Under the Curve 0 to Infinity (AUC0-∞)

    Time frame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.

    Note the standard deviation is actually the coefficient of variation (CV (%)).

  2. Maximum Measured Concentration (Cmax)

    Time frame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Maximum measured concentration of empagliflozin (empa) in plasma.

    Note the standard deviation is actually the CV (%).

Secondary outcomes

  1. Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

    Time frame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.

    Note the standard deviation is actually the CV (%).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of 25 mg BI 10773 (Final Formulation) Compared to 25 mg BI 10773 XX (Trial Formulation 2) Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)

Important dates

Study start
2010
Primary completion
2010
First posted
Nov 16, 2010
Registry last updated
Jun 18, 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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