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
- Registration Number
- NCT01766245
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Formulation B followed by Formulation A semaglutide - Formulation A followed by Formulation B semaglutide -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)