| Trial ID: | L6452 |
| Source ID: | NCT05549583
|
| Associated Drug: |
Sitagliptin/Metformin Hydrochloride (Hcl) 50/1000 Mg Film-Coated Tablet
|
| Title: |
Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Tablets in Healthy Male and Female Volunteers
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Bioequivalence|Type 2 Diabetes
|
| Interventions: |
DRUG: Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg 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 plasma concentration-time curve from zero to the time of the last measurable time point t, 48 hours | Secondary: Number of participants with adverse events (AEs), abnormal clinical laboratory test results, physical examination findings and glycemia., Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 20.1 (Medrio database) and graded as mild, moderate, or severe. The principal investigator or qualified designee determined the relationship of any AE to the investigational product., 1 week
|
| Sponsor/Collaborators: |
Sponsor: Galenicum Health
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
26
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2018-04-15
|
| Completion Date: |
2018-04-25
|
| Results First Posted: |
|
| Last Update Posted: |
2022-09-22
|
| Locations: |
Algorithme Pharma, Mount Royal, Quebec, H3P 3P1, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT05549583
|
