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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 concentration

tmax, 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

Page last updated: August 23, 2015

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