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

Novo Nordisk A/S0 sites28 target enrollmentDecember 2012

ConditionsDiabetes Healthy

Interventionssemaglutide

Drugssemaglutide

Overview

Phase: Phase 1
Intervention: semaglutide
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 28
Primary Endpoint: Area under the plasma semaglutide concentration curve
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

May 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Formulation A followed by Formulation B

Intervention: semaglutide

Formulation B followed by Formulation A

Intervention: semaglutide

Outcomes

Primary Outcomes

Area under the plasma semaglutide concentration curve

Time Frame: 0-4 weeks after a single dose s.c. semaglutide administration

Cmax, the maximum plasma semaglutide concentration

Time Frame: 20-40 hours after a single dose s.c. semaglutide administration

Secondary Outcomes

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))