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

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Healthy
Diabetes

Treatments

Drug: semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01766245
NN9535-4010
U1111-1130-3931 (Other Identifier)
2012-002212-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

28 participants in 2 patient groups

Formulation A followed by Formulation B
Experimental group
Treatment:
Drug: semaglutide
Formulation B followed by Formulation A
Active Comparator group
Treatment:
Drug: semaglutide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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