Bioequivalence of Two Insulatard® Formulations in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Formulation A

Group Type EXPERIMENTAL

isophane human insulin

Intervention Type DRUG

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

Formulation B

Group Type ACTIVE_COMPARATOR

isophane human insulin

Intervention Type DRUG

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

Interventions

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isophane human insulin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No