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

NCT ID: NCT03629054

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-27
• Study Completion Date: 2018-11-05

Brief Summary

The primary objective of this trial is to establish the bioequivalence of two empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC) tablets (Test, T) compared with the same doses of the individual components given in separate tablets (Reference, R) when administered together after a high-fat, high-calorie meal.

The assessment of safety and tolerability will be the secondary objective of this trial.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test treatment (T)

Low strength empagliflozin/linagliptin/metformin XR fixed dose combination tablet

Group Type: EXPERIMENTAL

Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination)

Intervention Type: DRUG

single dose

Reference treatment (R)

Single tablets of empagliflozin + linagliptin + metformin XR

Group Type: EXPERIMENTAL

Empagliflozin

Intervention Type: DRUG

single dose

Linagliptin

Intervention Type: DRUG

single dose

Metformin HCl

Intervention Type: DRUG

single dose

Interventions

Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination)

single dose

Intervention Type: DRUG

Empagliflozin

single dose

Intervention Type: DRUG

Linagliptin

single dose

Intervention Type: DRUG

Metformin HCl

single dose

Intervention Type: DRUG

Other Intervention Names

TRIJARDY® XR

Eligibility Criteria

Inclusion Criteria

• Healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (incl.)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
• Female subjects of childbearing potential willing to use adequate contraception.

Exclusion Criteria

• Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanpharmakologisches Zentrum Biberach

Biberach, , Germany

Countries

Germany

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2018-001266-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1361-0011

Identifier Type: -

Identifier Source: org_study_id