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Trial Outcomes & Findings for Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers (NCT NCT01242176)

NCT ID: NCT01242176

Last Updated: 2014-06-18

Results Overview

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 (%)).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

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

Results posted on

2014-06-18

Participant Flow

Participant milestones

Participant milestones
Measure
Empa FF / Empa TF2
Single dose of 25mg of empagliflozin (empa) final formulation (FF) followed by a single dose of 25mg empa trial formulation 2 (TF2), with a washout period of at least 7 days between treatments.
Empa TF2 / Empa FF
Single dose of 25mg empagliflozin (empa) trial formulation 2 (TF2) followed by a single dose of 25mg of empa final formulation (FF), with a washout period of at least 7 days between treatments.
First Intervention
STARTED
12
12
First Intervention
COMPLETED
12
12
First Intervention
NOT COMPLETED
0
0
Washout Period of 7 Days
STARTED
12
12
Washout Period of 7 Days
COMPLETED
11
10
Washout Period of 7 Days
NOT COMPLETED
1
2
Second Intervention
STARTED
11
10
Second Intervention
COMPLETED
11
10
Second Intervention
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Empa FF / Empa TF2
Single dose of 25mg of empagliflozin (empa) final formulation (FF) followed by a single dose of 25mg empa trial formulation 2 (TF2), with a washout period of at least 7 days between treatments.
Empa TF2 / Empa FF
Single dose of 25mg empagliflozin (empa) trial formulation 2 (TF2) followed by a single dose of 25mg of empa final formulation (FF), with a washout period of at least 7 days between treatments.
Washout Period of 7 Days
Adverse Event
0
2
Washout Period of 7 Days
Non-compliant with protocol
1
0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Study Overall
n=24 Participants
An open-label, randomised, two-way crossover study. The two treatments administered were * A single dose of empagliflozin (empa) 25mg, final formulation * A single dose of empa 25mg, trial formulation 2 Between drug administrations there was a washout period of at least 7 days.
Age, Continuous
36.3 years
STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.

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 (%)).

Outcome measures

Outcome measures
Measure
Empa FF
n=21 Participants
Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
Empa TF2
n=23 Participants
Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
Area Under the Curve 0 to Infinity (AUC0-∞)
5200 nmol*h/L
Standard Deviation 20.7
5090 nmol*h/L
Standard Deviation 17.7

PRIMARY outcome

Timeframe: 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

Population: Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.

Maximum measured concentration of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV (%).

Outcome measures

Outcome measures
Measure
Empa FF
n=21 Participants
Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
Empa TF2
n=23 Participants
Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
Maximum Measured Concentration (Cmax)
764 nmol/L
Standard Deviation 26.5
764 nmol/L
Standard Deviation 23.0

SECONDARY outcome

Timeframe: 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

Population: Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.

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 (%).

Outcome measures

Outcome measures
Measure
Empa FF
n=21 Participants
Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
Empa TF2
n=23 Participants
Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
5140 nmol*h/L
Standard Deviation 20.8
5030 nmol*h/L
Standard Deviation 18.0

Adverse Events

Empa FF

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Empa TF2

Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Empa FF
n=22 participants at risk
Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
Empa TF2
n=23 participants at risk
Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
Nervous system disorders
Migraine with aura
0.00%
0/22 • From drug administration until end of study visit, up to 10 days
4.3%
1/23 • From drug administration until end of study visit, up to 10 days

Other adverse events

Other adverse events
Measure
Empa FF
n=22 participants at risk
Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
Empa TF2
n=23 participants at risk
Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
Nervous system disorders
Headache
4.5%
1/22 • From drug administration until end of study visit, up to 10 days
17.4%
4/23 • From drug administration until end of study visit, up to 10 days

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place