Clinical Trial Details
| Trial ID: | L5641 |
| Source ID: | NCT04097600 |
| Associated Drug: | Oral Semaglutide |
| Title: | A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Healthy Volunteers|Type 2 Diabetes |
| Interventions: | DRUG: Oral semaglutide |
| Outcome Measures: | Primary: AUC0-24h,sema,SS; area under the semaglutide plasma concentration-time curve during a dosing interval at steady state, nmol\*h/L, From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively | Secondary: Cmax,sema,SS; maximum semaglutide plasma concentration at steady state, nmol/L, From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively|tmax,sema,SS; time to maximum semaglutide plasma contraction at steady state, h, From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively|t½,sema,SS; terminal half-life of semaglutide at steady state, h, Determined by concentrations measured between day 84 and follow-up at day 119 of semaglutide at steady state |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 274 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2019-09-30 |
| Completion Date: | 2021-01-20 |
| Results First Posted: | |
| Last Update Posted: | 2022-09-13 |
| Locations: | Novo Nordisk Investigational Site, Berlin, 14050, Germany |
| URL: | https://clinicaltrials.gov/show/NCT04097600 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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