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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:1/7/2017
Start Date:May 2005
End Date:November 2005

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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

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.


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
We found this trial at
1
site
San Antonio, Texas 78224
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from
San Antonio, TX
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