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

NCT ID: NCT01527630

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-16
• Study Completion Date: 2003-01-08

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Formulation A

Group Type: EXPERIMENTAL

biphasic insulin aspart 50

Intervention Type: DRUG

A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-21days

Formulation B

Group Type: EXPERIMENTAL

biphasic insulin aspart 50

Intervention Type: DRUG

A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-21days

Interventions

biphasic insulin aspart 50

A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-21days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Tokyo, , Japan

Countries

Japan

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

BIASP-1504

Identifier Type: -

Identifier Source: org_study_id