Status:
COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics of Two IDegAsp (One Explorative) Preparations and Two Insulin Degludec (One Explorative) Preparations in Japanese Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Asia. The aim of this trial is to assess the safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug ...
Eligibility Criteria
Inclusion
- Healthy Japanese male subjects
- Body mass index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
- Body weight above or equal to 50 kg
Exclusion
- The receipt of any investigational drug within 16 weeks prior to this trial (the planned first dosing)
- Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal electrocardiogram (ECG) findings at the screening, as judged by the investigator or sub-investigator
- Known or suspected allergy to trial product(s) or related products
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01868555
Start Date
December 1 2007
End Date
February 1 2008
Last Update
October 22 2015
Active Locations (1)
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1
Tokyo, Japan, 1000005