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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

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