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NCT06073600
Bioequivalence Study to Compare Metformin / Vildagliptin Versus Galvumet®
Phase 1 trial testing Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®) in Fed Conditions in 18 participants. Completed in 13 November 2022.
9 September 2022
Quick facts
| Lead sponsor | Reseach Laboratory of Clinical and Experimental Pharmacology |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 20 May 2022 |
| Primary completion | 9 September 2022 |
| Estimated completion | 13 November 2022 |
| Sites | 1 location across Tunisia |
Drugs / interventions tested
- Metformin / Vildagliptin Reference Film Coated Tablets (1000 mg / 50 mg) (Galvumet®) — full drug profile →
- Metformin / Vildagliptin Test Film Coated Tablets (1000 mg / 50 mg) — full drug profile →
Conditions studied
- Fed Conditions — all drugs for Fed Conditions →
Sponsor
Reseach Laboratory of Clinical and Experimental Pharmacology
Who can join
Adults 18 to 50, any sex, with Fed Conditions. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Pharmaceutical Arab Industries Society, Tunisia versus the reference product Galvumet® tablets (1000 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by Novartis. This study also aims to monitor the safety of the subjects. This study is an open label, randomized, fed, single oral dose, two-treatment, two-sequence, and two-period crossover study with a washout interval of at least one week between dosing. Eighteen (18) Tunisian subjects will be enrolled for this study. Subjects will be healthy volunteers, adults, aged between eighteen to fifty (18-50) years, (both inclusive), within the accepted limits for body height \& weight and meeting the selection criteria for this study.
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 NCT06073600
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Related trials
Other Reseach Laboratory of Clinical and Experimental Pharmacology trials
Trials by the same sponsor.
- NCT06103747 — Bioequivalence Study to Compare Metformin / Vildagliptin (850 mg/50 mg) Versus Galvumet® · 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 NCT06073600 (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 Reseach Laboratory of Clinical and Experimental Pharmacology
- Last refreshed: 25 October 2023
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/NCT06073600.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing