Skip to main content
OpenTrials
Completed

NCT Number: NCT01766245

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

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

Primary outcomes

  1. Area under the plasma semaglutide concentration curve

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

  2. Cmax, the maximum plasma semaglutide concentration

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

Secondary outcomes

  1. The area under the plasma semaglutide concentration curve

    Time frame: From time 0 to infinity after a single dose s.c. semaglutide administration

  2. tmax, time to Cmax of semaglutide

    Time frame: 20-40 hours

  3. t½, terminal elimination half-life of semaglutide

    Time frame: 140-200 hours

  4. Incidence of adverse events (AEs)

    Time frame: From first dosing to follow-up (5-7 weeks after the second dosing)

  5. Hypoglycaemic episodes

    Time frame: From first dosing to follow-up (5-7 weeks after the second dosing)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2013
Registry last updated
Jun 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.