Bioequivalence of Two Insulatard® Formulations in Healthy Subjects

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator

• Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2, inclusive

• Non-smoker, defined as no nicotine consumption for at least one year

• Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)

Exclusion Criteria:

• Previous participation in this trial or other clinical trials within the last 3 months

• Body weight above 87.5 kg

• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant)

• History of alcohol or drug abuse