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NCT07266766
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg
Phase 1 trial testing Empagliflozin / Metformin HCl XR Tablets in Type 2 Diabetes Mellitus (T2DM) in 40 participants. Completed in 6 October 2025.
24 September 2025
Quick facts
| Lead sponsor | Humanis Saglık Anonim Sirketi |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 40 |
| Start date | 5 August 2025 |
| Primary completion | 24 September 2025 |
| Estimated completion | 6 October 2025 |
| Sites | 1 location across India |
Drugs / interventions tested
- Empagliflozin / Metformin HCl XR Tablets — full drug profile →
- Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) — full drug profile →
Conditions studied
- Type 2 Diabetes Mellitus (T2DM) — all drugs for Type 2 Diabetes Mellitus (T2DM) →
Sponsor
Humanis Saglık Anonim Sirketi — full company profile →
Who can join
Adults 18 to 45, any sex, with Type 2 Diabetes Mellitus (T2DM). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, two way crossover, Oral Bioequivalence Study of test product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and Reference product of Synjardy XR tablets 25mg/1000mg in Healthy, adult, human Subjects Under fed Condition.
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 NCT07266766
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Empagliflozin / Metformin HCl XR Tablets
Trials testing the same drug.
- NCT07372118 — Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tabl · Phase 1 · completed
Other recruiting trials for Type 2 Diabetes Mellitus (T2DM)
Currently open trials in the same condition.
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- NCT07366775 — A Telenursing Program to Support Diabetes Self-Management · NA · active not recruiting
- NCT07398495 — Multimodal Training Effects in Middle-Aged and Older Adults With Diabetic Sarcopenia · NA · recruiting
- NCT07465224 — A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus · Phase 2 · recruiting
- NCT07442006 — Glycemic Variability of Combination Therapies in T2DM · Phase 4 · recruiting
Other Humanis Saglık Anonim Sirketi trials
Trials by the same sponsor.
- NCT07372118 — Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tabl · Phase 1 · completed
- NCT07278349 — Bioequivalence Study to Compare Vonoprazan 20 mg Film Coated Tablets Versus Voquezna® 20 mg (Vonoprazan) Tablets · Phase 1 · completed
- NCT07266779 — Bioequivalence Study of Test Product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg Film Coated Tablets and Reference Pr · Phase 1 · completed
- NCT07266792 — Bioequivalence Study to Compare Brexpiprazole 4 mg Film Coated Tablets Versus RXULTI 4 mg Film Coated Tablet (Brexpipraz · Phase 1 · completed
- NCT07098585 — To Compare and Evaluate the Oral Bioavailability of Lisdexamfetamine 70 mg Capsule With That of Elvanse® 70 mg Capsules, · Phase 1 · 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 NCT07266766 (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 Humanis Saglık Anonim Sirketi
- Last refreshed: 5 December 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/NCT07266766.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing