Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
A total of 72 subjects will be randomized in a 1:1:1 ratio to receive 10 mg glepaglutide SC via vial/syringe (Reference) twice or autoinjector (Test) in one of the 3 treatment sequences.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autoinjector - vial/syringe - vial/syringe | Experimental | Single dose of Glepaglutide 10 mg for each treatment sequence |
|
| vial/syringe - autoinjector - vial/syringe | Experimental | Single dose of Glepaglutide 10 mg for each treatment sequence |
|
| vial/syringe - vial/syringe - autoinjector | Experimental | Single dose of Glepaglutide 10 mg for each treatment sequence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glepaglutide | Drug | GLP-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Variables | Cmax = maximum concentration of ZP1848total in plasma | From time zero to the last time point with a measurable concentration |
| Pharmacokinetic Variables | AUC0-t = area under the plasma ZP1848total concentration-time curve (AUC) | from time zero to the last time point with a measurable concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Variables | Number of subject with AE/SAE as a measure of safety and tolerability | 16 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stine Just Maarbjerg, PhD | Zealand Pharma A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences- Location Martini | Groningen | NZ | 9728 | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|