Status:

COMPLETED

Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes

Healthy

Eligibility:

All Genders

18-55 years

Phase:

PHASE1

Brief Summary

This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence between two formulations of Mixtard® 30 in healthy subjects.

Eligibility Criteria

Inclusion

  • 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

  • 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
  • History of alcohol or drug abuse

Key Trial Info

Start Date :

May 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2006

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT01486888

Start Date

May 1 2006

End Date

July 1 2006

Last Update

March 18 2015

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Neuss, Germany, 41460