A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between subcutaneous injections of semaglutide produced by two manufacturing processes.

Official Title
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A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: semaglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects Body mass index (BMI) of 18.5-30 kg/m^2 (both incl.) Exclusion Criteria: History of or presence of cancer, diabetes, pancreatitis or any clinically relevant cardiovascular diseases or other major disorders Use of prescription or non-prescription medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide Smoking, drug or alcohol abuse Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or not using adequate contraceptive methods for the duration of the trial and for 3 months following the last dose of semaglutide

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation A followed by Formulation B<br> | Drug: semaglutide<br>* For subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits.<br>|
| Active Comparator: Formulation B followed by Formulation A<br> | Drug: semaglutide<br>* For subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma semaglutide concentration curve |  | 0-4 weeks after a single dose s.c. semaglutide administration | 
| Cmax, the maximum plasma semaglutide concentration |  | 20-40 hours after a single dose s.c. semaglutide administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under the plasma semaglutide concentration curve |  | From time 0 to infinity after a single dose s.c. semaglutide administration | 
| tmax, time to Cmax of semaglutide |  | 20-40 hours | 
| t½, terminal elimination half-life of semaglutide |  | 140-200 hours | 
| Incidence of adverse events (AEs) |  | From first dosing to follow-up (5-7 weeks after the second dosing) | 
| Hypoglycaemic episodes |  | From first dosing to follow-up (5-7 weeks after the second dosing) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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