Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese Subjects

• Status: Completed
• Trial end date: 2003-01-08
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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