| Trial ID: | L2370 |
| Source ID: | NCT01527630
|
| Associated Drug: |
Biphasic Insulin Aspart 50
|
| Title: |
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 50
|
| Outcome Measures: |
Primary: Area under the insulin aspart concentration-time curve in the interval from 0 to 16 hours|Cmax, maximum insulin aspart concentration | Secondary: Area under the insulin aspart concentration-time curve|Tmax, time to maximum insulin aspart concentration|MRT, mean residence time|t½, terminal half-life
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2002-11-16
|
| Completion Date: |
2003-01-08
|
| Results First Posted: |
|
| Last Update Posted: |
2017-02-24
|
| Locations: |
Novo Nordisk Investigational Site, Tokyo, 1000005, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01527630
|
