CompletedNCT01301742Updated Jun 18, 2014Results posted

Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With Empagliflozin (BI 10773) When Given Alone in Healthy Volunteers

A Phase 1 interventional study of BI 10773 and Gemfibrozil in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-18.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

To investigate the relative bioavailability of BI 10773 following coadministration with 600 mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.

Conditions studied

Healthy

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy male and female subjects

Exclusion criteria

Exclusion criteria:

Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 18 participants (actual)

Study arms

Active comparator
BI 10773
Subject to receive one single dose BI 10773
Drug: BI 10773 · Drug: Gemfibrozil
Experimental
BI 10773 plus gemfibrozil
Subject to receive one single dose BI 10773 plus 600 mg gemfibrozil bid for 5 days
Drug: BI 10773

Interventions

DrugBI 10773
1 tablet single dose BI 10773 in the morning
DrugGemfibrozil
Gemfibrozil 600 mg bid for 5 days
DrugBI 10773
1 tablet single dose BI 10773 in the morning

What researchers measure

Primary outcomes

Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).
Time frame: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Total Empa: Maximum Measured Concentration (Cmax)
Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).
Time frame: 0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose

Secondary outcomes

Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point. The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV).
Time frame: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose

Results

Posted Jun 18, 2014

Participant flow

First Intervention

Participant flow — First Intervention
Milestone	Empa First, Then Empa and Gemfibrozil	Empa and Gemfibrozil First, Then Empa
Started	9	9
Completed	9	9
Not completed	0	0

Washout Period of at Least 7 Days

Participant flow — Washout Period of at Least 7 Days
Milestone	Empa First, Then Empa and Gemfibrozil	Empa and Gemfibrozil First, Then Empa
Started	9	9
Completed	9	9
Not completed	0	0

Second Intervention

Participant flow — Second Intervention
Milestone	Empa First, Then Empa and Gemfibrozil	Empa and Gemfibrozil First, Then Empa
Started	9	9
Completed	9	9
Not completed	0	0

Outcome measures

PrimaryTotal Empa: Area Under the Curve 0 to Infinity (AUC0-∞)

Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).

Time frame:: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Reported as:: Geometric mean · nmol*h/L

Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
nmol*h/L	Empa Alone	Empa and Gemfibrozil
Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)	4708.33 ± 7.5	7462.74 ± 7.5

Statistical analysis

Empa Alone vs Empa and Gemfibrozil · ANOVA · Geometric mean ratio: 158.50 · 90% CI 151.77 to 165.53Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)

PrimaryTotal Empa: Maximum Measured Concentration (Cmax)

Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).

Time frame:: 0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Reported as:: Geometric mean · nmol/L

Total Empa: Maximum Measured Concentration (Cmax)
nmol/L	Empa Alone	Empa and Gemfibrozil
Total Empa: Maximum Measured Concentration (Cmax)	602.24 ± 13.8	692.59 ± 13.8

Statistical analysis

Empa Alone vs Empa and Gemfibrozil · ANOVA · Geometric mean ratio: 115.00 · 90% CI 106.15 to 124.59Standard deviation is actually the intra-individual gCV

SecondaryTotal Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)

Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point. The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV).

Time frame:: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Reported as:: Geometric mean · nmol*h/L

Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
nmol*h/L	Empa Alone	Empa and Gemfibrozil
Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)	4643.81 ± 7.7	7350.84 ± 7.7

Statistical analysis

Empa Alone vs Empa and Gemfibrozil · ANOVA · Geometric mean ratio: 158.29 · 90% CI 151.41 to 165.49Standard deviation is actually the intra-individual gCV

Adverse events

Collected over First administration of trial medication until next administration of trial medication or up to post-study visit, 20 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Empa Alone	—	0/18 (0%)	8/18 (44.4%)
Empa and Gemfibrozil	—	0/18 (0%)	3/18 (16.7%)
Gemfibrozil Alone	—	0/18 (0%)	6/18 (33.3%)

Most frequent other events

Showing 10 of 14

Most frequent other events
Event	Empa Alone	Empa and Gemfibrozil	Gemfibrozil Alone
HeadacheNervous system disorders	4/18	1/18	1/18
HaematomaVascular disorders	2/18	0/18	0/18
DiarrhoeaGastrointestinal disorders	0/18	0/18	1/18
DyspepsiaGastrointestinal disorders	0/18	0/18	1/18
Oral herpesInfections and infestations	1/18	0/18	0/18
RhinitisInfections and infestations	0/18	0/18	1/18
Muscle disorderMusculoskeletal and connective tissue disorders	1/18	0/18	0/18
Muscle tightnessMusculoskeletal and connective tissue disorders	1/18	0/18	0/18
Pain in extremityMusculoskeletal and connective tissue disorders	0/18	1/18	0/18
DizzinessNervous system disorders	1/18	1/18	0/18

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Entire Study Population
Mean	35.1 ± 10.2

Sex: Female, Male
Sex: Female, Male(Participants)	Entire Study Population
Female	7
Male	11

Study locations

1 site

1245.58.1 Boehringer Ingelheim Investigational Site
Biberach, Germany

References and documents

Publications

Macha S, Koenen R, Sennewald R, Schone K, Hummel N, Riedmaier S, Woerle HJ, Salsali A, Broedl UC. Effect of gemfibrozil, rifampicin, or probenecid on the pharmacokinetics of the SGLT2 inhibitor empagliflozin in healthy volunteers. Clin Ther. 2014 Feb 1;36(2):280-90.e1. doi: 10.1016/j.clinthera.2014.01.003. Epub 2014 Feb 1. PubMed 24491572 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01301742
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Feb 23, 2011
Start date: Feb 2011
Primary completion: May 2011
Results posted: Jun 18, 2014
Last update: Jun 18, 2014

Study contacts

Boehringer Ingelheim

study chair · Boehringer Ingelheim

View the source record on ClinicalTrials.gov ↗

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Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With Empagliflozin (BI 10773) When Given Alone in Healthy Volunteers

Study summary

Conditions studied

In context

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Updates

Registry details

Key details

Study contacts

Not currently enrolling

Follow this study

Discussion

Other studies from this sponsor

Inclusion criteria

Exclusion criteria