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Comparison of Two NN1250 Formulations in Healthy Volunteers

NCT00966368 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2015-09-28

No results posted yet for this study

Summary

This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.

Conditions

Interventions

DRUG

insulin degludec

Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin)

DRUG

insulin degludec

Single dose of NN1250, formulation 2, 0.4U/kg body weight injected subcutaneously (under the skin)

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00966368 on ClinicalTrials.gov