Trial · Interventional
CompletedPhase 1Registry dataA Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector.
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 85 participants (actual)
- Sponsor
- Zealand Pharma · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Netherlands
- Start
- 4 Mar 2020
- Primary completion
- 10 Jun 2021
- Completion
- 10 Jun 2021
- First posted
- 24 Mar 2020
- Last update posted
- 14 Jul 2021
- Conditions
- Healthy
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector.
NCT043187434 Mar 2020 to 10 Jun 2021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is an open-label, randomized, single center, 2-treatment, 3-period, 3-sequence reference-replicated, crossover trial in healthy subjects to compare the PK of glepaglutide (ZP1848) after a single SC administration by vial/syringe and by autoinjector.
Interventions
- GlepaglutideDrug
Arms3
Experimental
autoinjector - vial/syringe - vial/syringe
Single dose of Glepaglutide 10 mg for each treatment sequence
Experimental
vial/syringe - autoinjector - vial/syringe
Single dose of Glepaglutide 10 mg for each treatment sequence
Experimental
vial/syringe - vial/syringe - autoinjector
Single dose of Glepaglutide 10 mg for each treatment sequence
Primary outcomes2
Outcomes the sponsor listed as primary.
Pharmacokinetic Variables
Time frame · From time zero to the last time point with a measurable concentration
Registry description
Cmax = maximum concentration of ZP1848total in plasma
Pharmacokinetic Variables
Time frame · from time zero to the last time point with a measurable concentration
Registry description
AUC0-t = area under the plasma ZP1848total concentration-time curve (AUC)
Secondary outcomes(1)
Safety Variables
Time frame · 16 weeks
Registry description
Number of subject with AE/SAE as a measure of safety and tolerability
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 54 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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