| Trial ID: | L5792 |
| Source ID: | NCT06180109
|
| Associated Drug: |
Empagliflozin Film Coated Tablets
|
| Title: |
Bioequivalence Study of Empagliflozin 25 mg Film Coated Tablets of Humanis, Turkey and Jardiance (Empagliflozin) 25 mg Film-coated Tablets of Boehringer Ingelheim International GmbH, Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type2 Diabetes Mellitus
|
| Interventions: |
DRUG: Empagliflozin film coated tablets|DRUG: Jardiance film-coated tablets
|
| Outcome Measures: |
Primary: Maximum concentration obtained (Cmax), Two-sided 90% confidence intervals for ratio (test/reference) of the population means is within 80.00% to 125.00% for each of the Ln-transformed data Cmax, 48 hours|AUC from the 0 to infinity (AUC0-inf), Descriptive Statistics, 48 hours|Time of the maximum measured plasma concentration (Tmax), Descriptive Statistics, 48 hours |
|
| Sponsor/Collaborators: |
Sponsor: Humanis Saglık Anonim Sirketi
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2023-07-30
|
| Completion Date: |
2023-10-06
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| Results First Posted: |
|
| Last Update Posted: |
2023-12-22
|
| Locations: |
Raptim Research Pvt. Ltd.,, Navi Mumbai, India
|
| URL: |
https://clinicaltrials.gov/show/NCT06180109
|
