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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766245
• Other study ID #: NN9535-4010
• Secondary ID: 2012-002212-20U1
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2012
• Last updated: June 24, 2014
• Start date: December 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• semaglutide
For subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma semaglutide concentration curve		0-4 weeks after a single dose s.c. semaglutide administration	No
Primary	Cmax, the maximum plasma semaglutide concentration		20-40 hours after a single dose s.c. semaglutide administration	No
Secondary	The area under the plasma semaglutide concentration curve		From time 0 to infinity after a single dose s.c. semaglutide administration	No
Secondary	tmax, time to Cmax of semaglutide		20-40 hours	No
Secondary	t½, terminal elimination half-life of semaglutide		140-200 hours	No
Secondary	Incidence of adverse events (AEs)		From first dosing to follow-up (5-7 weeks after the second dosing)	No
Secondary	Hypoglycaemic episodes		From first dosing to follow-up (5-7 weeks after the second dosing)	No

External Links

•   Clinical Trials at Novo Nordisk