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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Formulation A followed by Formulation B

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

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

Formulation B followed by Formulation A

Group Type ACTIVE_COMPARATOR

semaglutide

Intervention Type DRUG

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

Interventions

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semaglutide

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes