Pharmacokinetics of Biphasic Insulin Aspart 50 and 70 in Japanese Healthy Volunteers
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Healthy
Intervention: biphasic insulin aspart 50 (Drug); biphasic insulin aspart 70 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Tomio Sasaki, Study Director, Affiliation: Novo Nordisk Pharma Ltd.
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.
Clinical Details
Official title: A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Characterizing the Pharmacokinetics and Pharmacodynamics of NN-X14Mix50 and NN-X14Mix70 in Healthy Male Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70)
Secondary outcome: Cmax, maximum insulin aspart concentrationtmax, time to maximum insulin aspart concentration t½, terminal elimination half life Mean residence time (MRT) Area under the curve from time 0 to infinity (0-∞) Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 50) Adverse events
Eligibility
Minimum age: 20 Years.
Maximum age: 40 Years.
Gender(s): Male.
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
Locations and Contacts
Tokyo 103, Japan
Additional Information
Clinical Trials at Novo Nordisk
Starting date: February 2000
Last updated: June 13, 2012
|