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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

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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01766245
Enrollment
28
Registered
2013-01-11
Start date
2012-12-31
Completion date
2013-05-31
Last updated
2014-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Keywords

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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.

Interventions

DRUGsemaglutide

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

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Area under the plasma semaglutide concentration curve0-4 weeks after a single dose s.c. semaglutide administration
Cmax, the maximum plasma semaglutide concentration20-40 hours after a single dose s.c. semaglutide administration

Secondary

MeasureTime frame
t½, terminal elimination half-life of semaglutide140-200 hours
The area under the plasma semaglutide concentration curveFrom time 0 to infinity after a single dose s.c. semaglutide administration
Hypoglycaemic episodesFrom first dosing to follow-up (5-7 weeks after the second dosing)
Incidence of adverse events (AEs)From first dosing to follow-up (5-7 weeks after the second dosing)
tmax, time to Cmax of semaglutide20-40 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026