Clinical trial
An Oral Single-dose, Randomized, Balanced, Open-label, Two-sequence, Two-treatment, Two-period, Crossover Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended Release Film Coated Tablets 50 mg / 500 mg (FDC) of Galenicum Health S.L.U., Spain With That of JANUMET® XR (Sitagliptin Phosphate / Metformin Hydrochloride) Extended-release Coated Tablets 50 mg / 500 mg (FDC) of Merck Sharp & Dohme Pharmaceuticals Ltd., Brazilin Healthy Adult Male and Female Subjects Under Fed Conditions.
NCT06124547 is registered in ClinicalTrials.gov with Galenicum Health as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- An Oral Single-dose, Randomized, Balanced, Open-label, Two-sequence, Two-treatment, Two-period, Crossover Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended Release Film Coated Tablets 50 mg / 500 mg (FDC) of Galenicum Health S.L.U., Spain With That of JANUMET® XR (Sitagliptin Phosphate / Metformin Hydrochloride) Extended-release Coated Tablets 50 mg / 500 mg (FDC) of Merck Sharp & Dohme Pharmaceuticals Ltd., Brazilin Healthy Adult Male and Female Subjects Under Fed Conditions.
- Lead sponsor
- Galenicum Health
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- January 16, 2023
- Completion date
- February 13, 2023
- Enrollment
- 48 (actual)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.
bioequivalence, diabetes mellitus, type 2