| Trial ID: | L3610 |
| Source ID: | NCT06124495
|
| Associated Drug: |
Sitagliptin/Metformin Hcl 50/500 Mg Extended Release Film-Coated Tablet
|
| Title: |
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Bioequivalence|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet
|
| Outcome Measures: |
Primary: Peak Plasma Concentration (Cmax), Evaluation of Peak Plasma Concentration (Cmax), 48 hours|Area under the plasma concentration versus time curve (AUC) 0-t, Evaluation of Area Under Plasma Concentration-Time Curve from Time Zero to the Last Measurable Concentration, 48 hours|Area under the plasma concentration versus time curve (AUC) 0-inf (Metformin only), Area Under Plasma Concentration-Time Curve from Time 0 to Infinite, 48 hours | Secondary: Number of participants with adverse events (AEs), To evaluate the safety and tolerability of a single oral dose of Sitagliptin /Metformin extended-release film coated tablets 50 mg /500 mg (FDC) under fasting conditions, 1 week
|
| Sponsor/Collaborators: |
Sponsor: Galenicum Health
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
58
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2023-01-13
|
| Completion Date: |
2023-02-13
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| Results First Posted: |
|
| Last Update Posted: |
2023-11-09
|
| Locations: |
Avant Santé Research Center S.A. de C.V., San Pedro Garza García, Nuevo León, 66260, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT06124495
|
