| Trial ID: | L4298 |
| Source ID: | NCT01490658
|
| Associated Drug: |
Repaglinide
|
| Title: |
Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: repaglinide|DRUG: metformin|DRUG: repaglinide and metformin combination tablet
|
| Outcome Measures: |
Primary: Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet administration|Repaglinide and metformin AUC (Area under the Curve) NN4440 (2/500) combination tablet|Repaglinide and metformin Cmax (maximum plasma concentration) fed state concomitant tablet administration|NN4440 (2/500) Cmax (maximum plasma concentration) combination tablet | Secondary: Repaglinide AUC after NN4440 (1/500) during fed state|Repaglinide Cmax after NN4440 ((1/500) during fed state|Change in physical examinations from screening|Vital signs
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
93
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-06
|
| Completion Date: |
2006-08
|
| Results First Posted: |
|
| Last Update Posted: |
2017-02-10
|
| Locations: |
Novo Nordisk Investigational Site, Austin, Texas, 78744, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01490658
|