Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460, Germany
NCT Number: NCT02660502
This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects.
Each subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits.
The total trial maximum duration for a subject will be up to 10 weeks.
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Notify Me20 year–64 year
All sexes
Interventional
Phase 1
Neuss, 41460, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg
Injection of a single dose of Humalog® at the dose of 0.2 U/kg
Time frame: Up to 30 minutes
Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes
Time frame: Up to 8 hours
Area under the glucose infusion rate time curve from 0 hours until the end of clamp
Time frame: Up to 10 weeks
Number of adverse events
Adocia
Industry
A Double-blind, Comparator-controlled, Randomised, Three-period Crossover Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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