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Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers

Bioequivalence of Two Biphasic Insulin Aspart 30 (NovoLog® Mix 70/30) Formulations (Current and New Formulation With Glycerol): A Randomized, Double-Blind, Two-Period Crossover Study in Healthy Volunteers

NCT01487811•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•BMI (body mass index) between 18 and 28 kg/m\^2, both inclusive
•Subject is a nonsmoker for at least 3 months
•Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
•Fasting plasma glucose between 80 and 110 mg/dl

Exclusion Criteria

••Any clinically significant disease history of systemic or organ disease
••Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
••In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative

Locations (1)

Novo Nordisk Investigational Site

San Antonio, Texas, United States

Key Dates

Start Date

May 1, 2005

Primary Completion Date

November 1, 2005

Completion Date

November 1, 2005

Last Updated

January 6, 2017

Enrollment

ACTUAL participants

Conditions

DiabetesHealthy

Interventions

biphasic insulin aspart 30

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

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