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Bioequivalence of Two Insulatard® Formulations in Healthy Subjects

NCT01486901 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2015-04-28

No results posted yet for this study

Summary

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.

Conditions

Interventions

DRUG

isophane human insulin

Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits

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
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • Germany

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 NCT01486901 on ClinicalTrials.gov