MedDataX Logo

Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets

NCT ID: NCT01844531

Last Updated: 2015-07-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin \[Test 1\] and low dose empagliflozin/500 mg metformin \[Test 2\]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet \[Reference 1\] and low dose empagliflozin tablet + Glucophage® 500 mg tablet \[Reference 2\]) when administered together after a high fat, high caloric meal.

The assessment of safety and tolerability will be an additional objective of this trial.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together

NCT01811953

Healthy
COMPLETED PHASE1

Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets

NCT01672788

Healthy
COMPLETED PHASE1

Demonstrate Bioequivalence of Two 12.5 mg Empagliflozin/500 mg Metformin Fixed Dose Combination Tablets With Free Combination of Empagliflozin 25 mg and Metformin 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions

NCT02577315

Healthy
COMPLETED PHASE1

Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets

NCT02028767

Healthy
COMPLETED PHASE1

Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Male and Female

NCT02266472

Healthy
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FDC empagliflozin dose 1 and metformin

fix dose combination tablet after intake of a high fat, high caloric meal

Group Type EXPERIMENTAL

empagliflozin and metformin

Intervention Type DRUG

FDC tablet empagliflozin and metformin

empagliflozin dose 1 + metformin tablets

single tablets after intake of a high fat, high caloric meal

Group Type ACTIVE_COMPARATOR

empagliflozin

Intervention Type DRUG

single tablet empagliflozin

metformin (Glucophage®)

Intervention Type DRUG

single tablet metformin

FDC empagliflozin dose 2 and metformin

fix dose combination tablet after intake of a high fat, high caloric meal

Group Type EXPERIMENTAL

empagliflozin and metformin

Intervention Type DRUG

FDC tablet empagliflozin and metformin

empagliflozin dose 2 + metformin tablets

single tablets after intake of a high fat, high caloric meal

Group Type ACTIVE_COMPARATOR

metformin (Glucophage®)

Intervention Type DRUG

single tablet metformin

empagliflozin

Intervention Type DRUG

single tablet empagliflozin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

empagliflozin

single tablet empagliflozin

Intervention Type DRUG

metformin (Glucophage®)

single tablet metformin

Intervention Type DRUG

metformin (Glucophage®)

single tablet metformin

Intervention Type DRUG

empagliflozin

single tablet empagliflozin

Intervention Type DRUG

empagliflozin and metformin

FDC tablet empagliflozin and metformin

Intervention Type DRUG

empagliflozin and metformin

FDC tablet empagliflozin and metformin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Healthy male and female subjects
2. Subjects must be able to understand and comply with study requirements
3. Age 18 to 50 years
4. Body mass index (BMI) 18.5 to 29.9 kg/m2

Exclusion Criteria

1\. Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1276.6.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-000082-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1276.6

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bioequivalence Study of Two Strengths of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects
NCT02183571 COMPLETED PHASE1
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects
NCT02230995 COMPLETED PHASE1
Bioequivalence of a Linagliptin / Metformin Fixed-dose Combination (FDC) Tablet Compared With Single Linagliptin and Metformin Tablets Administered Together in Healthy Volunteers
NCT02221401 COMPLETED PHASE1
Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.
NCT01089205 COMPLETED PHASE1
Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
NCT01581931 COMPLETED PHASE1
To Compare the Similarity of a Combination Dapagliflozin/Metformin Tablet With the Two Drugs Administered Separately
NCT01535677 COMPLETED PHASE1
This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood
NCT03259490 COMPLETED PHASE1
This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills
NCT03629054 COMPLETED PHASE1
A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metformin 50/10/1000mg is Compared to Taking Gemigliptin 50mg Separately With Dapagliflozin/Metformin 10/1000mg in Healthy Adults After a Meal
NCT07333742 COMPLETED PHASE1
Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fed, Healthy, Adult Subjects
NCT00944346 COMPLETED PHASE1
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.
NCT02084056 COMPLETED PHASE1
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin IR Tablets (2 x 850 mg) in Healthy Volunteers
NCT01518712 COMPLETED PHASE1
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Linagliptin Compared With the Free Combination of Empagliflozin Tablet and Linagliptin Tablet in Healthy Male and Female Subjects
NCT02758171 COMPLETED PHASE1
A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
NCT01649297 COMPLETED PHASE2
Bioequivalence of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Volunteers
NCT02221414 COMPLETED PHASE1
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)
NCT00961480 COMPLETED PHASE1
A Study in Healthy Humans to Assess the Relative Bioavailability of One Fixed-dose Combination Tablet Empagliflozin/Metformin Versus Jardiance® Tablet and Glifage® Tablet Administered Together
NCT05083949 COMPLETED PHASE1
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Volunteers
NCT01454622 COMPLETED PHASE1
Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability
NCT01211197 COMPLETED PHASE1
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone
NCT02670018 UNKNOWN PHASE1
Bioequivalence Study of Metformin Component of Canagliflozin and Metformin Fixed Dose Combination Immediate Release (IR) Tablet Comparing With Metformin IR Tablet Co-administered With Canagliflozin Tablet in Healthy Fed and Fasted Participants
NCT02220218 COMPLETED PHASE1
Bioequivalence Study for Acarbose/Metformin FDC
NCT04065581 COMPLETED PHASE1
Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fasting Conditions.
NCT01089192 COMPLETED PHASE1
Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
NCT01167881 COMPLETED PHASE3
Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects
NCT00944177 COMPLETED PHASE1