Study S001850

A Comparative Bioavailability Trial of Steady State Semaglutide Exposure With the Current Formulation (Semaglutide) and a New Formulation (Semaglutide C) of Oral Semaglutide in Healthy Subjects

ClinicalTrials.gov record

Registration

Registration: NCT04109508
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 278
Start: 2019-10-02
Primary completion: 2020-12-24
Lead sponsor: Novo Nordisk A/S
Conditions: Healthy Volunteers; Type 2 Diabetes
Interventions: DRUG:Oral semaglutide
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1233-0878; REGISTRY:2019-002010-40; NIH:2019

Registered primary outcomes

AUC0-24h,sema,SS; area under the semaglutide plasma concentration-time curve during a dosing interval at steady state [From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively]

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