Parexel CPRU, Level 7
Harrow, Middlesex, HA1 3UJ, United Kingdom
NCT Number: NCT05232708
In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. Participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1 and Period 2.
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Notify Me20 year–55 year
All sexes
Interventional
Phase 1
Harrow, Middlesex, HA1 3UJ, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.
Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.
Time frame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Measured in h*nmol/L
Time frame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Measured in nmol/L
Novo Nordisk A/S
Industry
A Study to Demonstrate Bioequivalence Between Semaglutide Formulation for the DV3396 Pen-injector and the Formulation for the PDS290 Semaglutide Pen-injector
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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