Study S000957

Relative Bioavailability of an Investigational Single Dose of Dulaglutide After Subcutaneous Administration by a Single Dose Pen Compared to a Prefilled Syringe in Healthy Subjects

ClinicalTrials.gov record Statistical Analysis Plan (PDF)Study Protocol (PDF)

Registration

Registration: NCT03363906
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 27
Start: 2017-12-07
Primary completion: 2018-06-06
Lead sponsor: Eli Lilly and Company
Conditions: Healthy
Interventions: DRUG:Dulaglutide (Reference); DRUG:Dulaglutide (Test)
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:H9X-MC-GBGM

Registered primary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide [Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up: Day 28]
PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide [Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up : Day 28]

Linked records (0)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

No records link to this registration yet.