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NCT07372118
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in Fast Condition
Phase 1 trial testing Empagliflozin / Metformin HCl XR Tablets in Type 2 Diabetes Mellitus (T2DM) in 32 participants. Completed in 7 January 2026.
29 December 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 | 32 |
| Start date | 27 September 2025 |
| Primary completion | 29 December 2025 |
| Estimated completion | 7 January 2026 |
| 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
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in fast 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 NCT07372118
- 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.
- NCT07266766 — 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.
- NCT07533539 — Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration · Phase 1 · recruiting
- 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.
- 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
- NCT07266766 — Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tabl · 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 NCT07372118 (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: 28 January 2026
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/NCT07372118.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing