A bridging trial to compare the pharmacokinetics of Glepaglutide (ZP1848) after a single subcutaneous administration by vial/syringe and by autoinjector in healthy subjects: a phase 1, randomized, open-label, three-way, reference-replicated crossover trial
- Conditions
- BioequivalenceHealthy volunteers
- Registration Number
- NL-OMON49360
- Lead Sponsor
- Zealand Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
1. Informed consent of the subject has to e obtained before any trial-related
activities are performed (trial-related activities are any procedures that
would not have been performed during normal management of the subject).
2. Subject has to be a healthy male or female aged between 18 years and 54
years, both inclusive, at screening.
3. Body mass index (BMI)of the subject has to be >20.0 kg/m2 and <29.9 kg/m2,
both inclusive, at screening.
4. Subject is willing to maintain a stable weight for the duration of the trial.
5. Subject is in overall good health according to age (medical history,
physical examination, vital signs, and laboratory assessments), as judged by
the Investigator at screening.
1. Subject cannot have a significant medical history or clinical manifestation
of any metabolic, allergic, dermatological, hepatic, renal, hematological,
pulmonary, cardiovascular, gastrointestinal, neurological, respiratory,
endocrine, or psychiatric disorder, as determined by the Investigator.
2. Subject with a history of colon cancer or a history of other cancers within
the last 5 years.
3. The physical examination of the subject should not show clinically
significant abnormalities in the standard 12-lead ECG, or vital signs
measurements as determined by the Investigator.
4. Clinically significant abnormality in hematology, clinical chemistry, or
urinalysis as determined by the Investigator (congenital nonhemolytic
hyperbilirubinemia [eg, Gilbert*s syndrome] is acceptable).
5. Subject cannot have a history of significant hypersensitivity, intolerance,
suspected hypersensitivity to glepaglutide or related products, or allergy to
any drug compound, food, or other substance, unless approved by the
Investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Cmax = maximum concentration of ZP1848total in plasma<br /><br>• AUC0-t = area under the plasma ZP1848total concentration-time curve (AUC)<br /><br>from time zero to the last time point with a measurable concentration both for<br /><br>the conceptual analyte ZP1848total (glepaglutide + ZP18481-34 + ZP18481-35) in<br /><br>plasma</p><br>
- Secondary Outcome Measures
Name Time Method