This trial is conducted in Europe. The aim of this trial is to show that the product of the
new production process has a similar pharmacological profile to the traditional process used
for the current commercial product Actrapid®.
Drug: human insulin
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01448070
Ages eligible for Study
18 Years to 50 Years
Genders eligible for Study
Accepts Healthy Volunteers
Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
Fasting blood glucose below or equal to 6 mmol/L
Body Mass Index (BMI) 22.0-27.0 kg/m^2 (both inclusive)
Participated in another clinical study with an investigational drug within the last 4 weeks
Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
Known or suspected allergy to the trial product or related products
Family history of type 1 diabetes
All locations for NCT01448070
United Kingdom (1)
Manchester, United Kingdom, M15 6SH
Manchester, United Kingdom
View full eligibility
Tris trial is registered with FDA with number: NCT01448070. The sponsor of the trial is Novo Nordisk A/S and it is looking for 28 volunteers for the current phase.
Official trial title: A Single Centre, Randomized, Balanced Double Blind, Cross-over Trial Investigating the Bioequivalence of Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 Process
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