| Trial ID: | L2852 |
| Source ID: | NCT06792968
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| Associated Drug: |
Empagliflozin + Metformin Hydrochloride 5 Mg/1000 Mg Combination Film-Coated Tablets
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| Title: |
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Diabetes Mellitus Type 2
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| Interventions: |
DRUG: Empagliflozin + Metformin hydrochloride 5 mg/1000 mg combination film-coated tablets|DRUG: Synjardy 5 mg/1000 mg film-coated tablets
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| Outcome Measures: |
Primary: 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), The primary purpose of the study is to assess the bioequivalence of Empagliflozin + Metformin hydrochloride 5 mg/1000 mg film-coated tablets (Gedeon Richter Plc., Hungary) and Synjardy 5 mg/1000 mg film-coated tablets (Boehringer Ingelheim International GmbH, Germany) in healthy, adult volunteers under fed conditions. The measurement will be based on two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data of AUC., From enrollment to the end of treatment at about 7 weeks|Bioequivalence of Empagliflozin + Metformin hydrochloride film-coated tablets and Synjardy® film-coated tablets via measuring the maximum concentration in plasma (Cmax), The primary purpose of the study is to assess the bioequivalence of Empagliflozin + Metformin hydrochloride 5 mg/1000 mg film-coated tablets (Gedeon Richter Plc., Hungary) and Synjardy 5 mg/1000 mg film-coated tablets (Boehringer Ingelheim International GmbH, Germany) in healthy, adult volunteers under fed conditions. The measurement will be based on two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data of Cmax., From enrollment to the end of treatment at about 7 weeks | Secondary: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], The secondary purpose is to assess the safety and tolerability of the study products from the signing of the informed consent form (ICF) until the end of the study. There will be no formal statistical evaluation of safety or tolerability. The safety results will be provided as listings and summary tables for each treatment group. Adverse event data listing will include AEs onset and resolution date/time, duration, time from dosing, severity, relationship to the IMP and/or the additional drug product, outcome, and the action taken to the IMP and/or additional drug product and to treat the AE., From enrollment to the end of treatment at about 7 weeks
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| Sponsor/Collaborators: |
Sponsor: Gedeon Richter Plc.
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| Gender: |
ALL
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| Age: |
ADULT
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| Phases: |
PHASE1
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| Enrollment: |
64
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2025-03-30
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| Completion Date: |
2025-04-08
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| Results First Posted: |
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| Last Update Posted: |
2025-04-13
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| Locations: |
State Budgetary Institution of Healthcare of Yaroslavl region "Yaroslavl Regional Clinical Narcological Hospital, Yaroslavl, 150054, Russian Federation
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| URL: |
https://clinicaltrials.gov/show/NCT06792968
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