Pharmacokinetics of Biphasic Insulin Aspart 50 and 70 in Japanese Healthy Volunteers

• Status: Completed
• Trial end date: 2000-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70 (NN-X14Mix70) in Japanese healthy volunteers.

• 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, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Healthy

• Japanese

• Body Mass Index (BMI) of 19-27 kg/m^2 (both inclusive)

• Fasting blood glucose between 3.8-6 mmol/L (68.4-108.0 mg/dL) (both inclusive

• Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator

Exclusion Criteria:

• Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator or Sub-Investigator(s)

• Any serious systemic infectious disease that occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator

• Any inter-current illness that may affect blood glucose, as judged by the Investigator or Sub-Investigator

• Hepatitis B or C, or HIV (human immunodeficiency virus)

• Use of prescription drugs within 2 weeks preceding the screening

• Use of non-prescription drugs, except routine vitamins or drugs that may not

• Blood donation of more than 1150 mL within the last 12 months

• Subjects with a first degree relative with diabetes mellitus

• History of or presence of diabetes

• History of or presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder

• Previous history of serious allergy or anaphylactic reaction

• Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse

• Subjects who smoke more than 5 cigarettes per day