Trial · NCT01301742

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

NCT01301742, Phase 1, Completed, Boehringer Ingelheim; results first posted 2014-06-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT01301742. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01301742

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT01301742
Status: Completed
Phases: Phase 1
Enrollment: 18 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Healthy
Interventions: BI 10773, Gemfibrozil, BI 10773
First posted: 2011-02-23
Last updated: 2014-06-18
Other registries' IDs: eudract:2010-023152-85
Results first posted: 2014-06-18

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)	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	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).
Primary	Total Empa: Maximum Measured Concentration (Cmax)	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	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).
Secondary	Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)	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	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).

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)	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	PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.	nmol*h/L	GEOMETRIC_MEAN
PRIMARY	Total Empa: Maximum Measured Concentration (Cmax)	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	PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.	nmol/L	GEOMETRIC_MEAN
SECONDARY	Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)	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	PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.	nmol*h/L	GEOMETRIC_MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)	Empa Alone	4708.33	Geometric Coefficient of Variation 7.5	nmol*h/L
Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)	Empa and Gemfibrozil	7462.74	Geometric Coefficient of Variation 7.5	nmol*h/L
Total Empa: Maximum Measured Concentration (Cmax)	Empa Alone	602.24	Geometric Coefficient of Variation 13.8	nmol/L
Total Empa: Maximum Measured Concentration (Cmax)	Empa and Gemfibrozil	692.59	Geometric Coefficient of Variation 13.8	nmol/L
Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)	Empa Alone	4643.81	Geometric Coefficient of Variation 7.7	nmol*h/L
Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)	Empa and Gemfibrozil	7350.84	Geometric Coefficient of Variation 7.7	nmol*h/L

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention	STARTED	Empa First, Then Empa and Gemfibrozil	9
First Intervention	STARTED	Empa and Gemfibrozil First, Then Empa	9
First Intervention	COMPLETED	Empa First, Then Empa and Gemfibrozil	9
First Intervention	COMPLETED	Empa and Gemfibrozil First, Then Empa	9
First Intervention	NOT COMPLETED	Empa First, Then Empa and Gemfibrozil	0
First Intervention	NOT COMPLETED	Empa and Gemfibrozil First, Then Empa	0
Washout Period of at Least 7 Days	STARTED	Empa First, Then Empa and Gemfibrozil	9
Washout Period of at Least 7 Days	STARTED	Empa and Gemfibrozil First, Then Empa	9
Washout Period of at Least 7 Days	COMPLETED	Empa First, Then Empa and Gemfibrozil	9
Washout Period of at Least 7 Days	COMPLETED	Empa and Gemfibrozil First, Then Empa	9

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Empa Alone	0	18
other	Diarrhoea	Gastrointestinal disorders	Empa and Gemfibrozil	0	18
other	Diarrhoea	Gastrointestinal disorders	Gemfibrozil Alone	1	18
other	Dyspepsia	Gastrointestinal disorders	Empa Alone	0	18
other	Dyspepsia	Gastrointestinal disorders	Empa and Gemfibrozil	0	18
other	Dyspepsia	Gastrointestinal disorders	Gemfibrozil Alone	1	18
other	Oral herpes	Infections and infestations	Empa Alone	1	18
other	Oral herpes	Infections and infestations	Empa and Gemfibrozil	0	18
other	Oral herpes	Infections and infestations	Gemfibrozil Alone	0	18
other	Rhinitis	Infections and infestations	Empa Alone	0	18

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Empa Alone
Total, all-cause mortality	Empa and Gemfibrozil
Total, all-cause mortality	Gemfibrozil Alone
Total, other adverse events	Empa Alone	8	18
Total, other adverse events	Empa and Gemfibrozil	3	18
Total, other adverse events	Gemfibrozil Alone	6	18
Total, serious adverse events	Empa Alone	0	18
Total, serious adverse events	Empa and Gemfibrozil	0	18
Total, serious adverse events	Gemfibrozil Alone	0	18

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24491572	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01301742

GET https://conductscience.org/api/trials/v1/NCT01301742/events?page=2

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