Trials / Completed
CompletedNCT04318743
A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector.
A Bridging Trial to Compare the Pharmacokinetics of Glepaglutide (ZP1848) After Single Subcutaneous Adminstration by Vial/Syringe and by Autoinjector in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- Zealand Pharma · Industry
- Sex
- All
- Age
- 18 Years – 54 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Glepaglutide | GLP-2 |
Timeline
- Start date
- 2020-03-04
- Primary completion
- 2021-06-10
- Completion
- 2021-06-10
- First posted
- 2020-03-24
- Last updated
- 2021-07-14
Locations
1 site across 1 country: Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04318743. Inclusion in this directory is not an endorsement.