Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy® 5 mg/850 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)

Sponsor
Gedeon Richter Plc.
Study ID
NCT06766500
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

Empagliflozin and metformin hydrochloride are two separate drugs. The combination of these two drugs in one tablet are used for the treatment of type 2 diabetes, along with diet and exercise, and can be used with other drugs, if required. It is approved in Russia and also various other countries. In Russia, the brand name is Synjardy®. The purpose of this research study is to measure the amount of the two drugs in the blood after taking two different formulations of the combination tablet. One formulation, also called Synjardy®, is an approved product in Russia marketed by Boehringer Ingelheim International GmbH, Germany. The other formulation is an investigational product that is not approved. The data from this study will be used to compare the two products. Subjects participating in this study will take 5 mg empagliflozin and 850 mg metformin hydrochloride (1 combination film-coated tablet) of one formulation in each period. The maximum recommended daily dose is 25 mg of empagliflozin and 2,000 mg of metformin hydrochloride which is based on the subject's current regimen \[prescribed course of medical treatment\], effectiveness, and tolerability.

Key Dates

Start date
Jan 20, 2025
Status verified
Mar 2025
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025

Study Design

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

Arms

  • Experimental: Empagliflozin + Metformin hydrochloride combination film-coated tablets
    Combination tablet of Empagliflozin + Metformin hydrochloride 5 mg/850 mg of Gedeon Richter Plc., Hungary
  • Active Comparator: Synjardy® film-coated tablets
    Synjardy® 5 mg/850 mg of Boehringer Ingelheim International GmbH, Germany

Primary Outcome Measure

Bioequivalence of Empagliflozin + Metformin hydrochloride film-coated tablets and Synjardy® film-coated tablets via measuring the AUC from time 0 to last collection time t (AUC0-t) [ Time Frame: From enrollment to the end of treatment at about 7 weeks ]

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