| Trial ID: | L6097 |
| Source ID: | NCT05227196
|
| Associated Drug: |
Semaglutide D Dose 1
|
| Title: |
A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Healthy Volunteers|Type 2 Diabetes
|
| Interventions: |
DRUG: Semaglutide D Dose 1|DRUG: Semaglutide D Dose 2|DRUG: Semaglutide D Dose 3|DRUG: Semaglutide Dose 4|DRUG: Semaglutide Dose 5|DRUG: Semaglutide Dose 6
|
| Outcome Measures: |
Primary: AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS), h∙nmol/L, 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.|Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state, nmol/L, 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154. | Secondary: tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state, h, 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.|Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state, nmol/L, 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
546
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-02-04
|
| Completion Date: |
2023-08-08
|
| Results First Posted: |
|
| Last Update Posted: |
2024-09-19
|
| Locations: |
Altasciences Clinical LA, Inc., Cypress, California, 90630, United States|Altasciences Clinical Kansas, Inc., Overland Park, Kansas, 66212, United States|Altasciences Company Inc., Montreal, Quebec, H3P 3P1, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT05227196
|
