Status:
COMPLETED
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
MALE
20-50 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.
Eligibility Criteria
Inclusion
- Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator.
- Body Mass Index (BMI) between 19-29 kg/m\^2 (inclusive)
- Fasting plasma glucose between 3.8-6.0 mmol/L (both inclusive)
Exclusion
- Clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator or Sub-Investigator
- Any serious systemic infectious disease that had occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
- Any inter-current illness that might affect blood glucose, as judged by the Investigator or Sub-Investigator
- Hepatitis B or C, or HIV (human immunodeficiency virus) positive
- Subjects with a first degree relative with diabetes mellitus
- History of or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder
- Subjects who consumed more than 28 units of alcohol per week or who had a significant history of alcoholism or drug/chemical abuse
- Subjects who smoked more than 5 cigarettes per day
- Subjects who had taken part in strenuous exercise within 7 days prior to the screening
Key Trial Info
Start Date :
November 16 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2003
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01527630
Start Date
November 16 2002
End Date
January 8 2003
Last Update
February 24 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005