Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects

Novo Nordisk A/S45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Healthy

Interventions

biphasic human insulin 30DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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 * History of alcohol or drug abuse

Locations (1)

Unnamed facility

Neuss, Germany

Outcomes

Primary Outcomes

Area under the serum insulin concentration-time curve (AUC 0-24 hours)

Maximum serum insulin concentration (Cmax)

Secondary Outcomes

Area under the serum insulin concentration-time curve (AUC 0-6 hours)

Area under the serum insulin concentration-time curve (AUC 6-24 hours)

Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)

Time to maximum serum insulin concentration (tmax)

Terminal insulin half life (t½)

Adverse events

Data from ClinicalTrials.gov

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