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

Sponsor
Boehringer Ingelheim
Study ID
NCT03629054
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 27, 2018
Status verified
Feb 2020
Primary completion
Nov 5, 2018
Completion
Nov 5, 2018

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Test treatment (T)
    Low strength empagliflozin/linagliptin/metformin XR fixed dose combination tablet
  • Experimental: Reference treatment (R)
    Single tablets of empagliflozin + linagliptin + metformin XR

Primary Outcome Measure

Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) [ Time Frame: Pharmacokinetic (PK) samples were collected 1:30 hours:minutes (h:m) pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration. ]

Related Studies