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NCT06766500
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)
Phase 1 trial testing Empagliflozin + Metformin hydrochloride 5 mg/850 mg combination film-coated tablets in Diabetes Mellitus Type 2 in 64 participants. Completed in 28 February 2025.
28 February 2025
Quick facts
| Lead sponsor | Gedeon Richter Plc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 20 January 2025 |
| Primary completion | 28 February 2025 |
| Estimated completion | 28 February 2025 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Empagliflozin + Metformin hydrochloride 5 mg/850 mg combination film-coated tablets — full drug profile →
- Synjardy® 5 mg/850 mg film-coated tablets — full drug profile →
Conditions studied
- Diabetes Mellitus Type 2 — all drugs for Diabetes Mellitus Type 2 →
Sponsor
Gedeon Richter Plc. — full company profile →
Who can join
Adults 18 to 45, any sex, with Diabetes Mellitus Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06766500
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Gedeon Richter Plc. trials
Trials by the same sponsor.
- NCT06990204 — Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets (Gedeon Richter Plc., Hungary) and Edarbi® 80 mg Tablets (JSC · Phase 1 · not yet recruiting
- NCT06823856 — Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets ( · Phase 1 · completed
- NCT06792968 — Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/1000 mg Film-coated Tablets (Ged · Phase 1 · completed
- NCT05322096 — Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome · Phase 2 · completed
- NCT05087030 — Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06766500 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gedeon Richter Plc.
- Last refreshed: 16 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06766500.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing