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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01620333
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted

June 13, 2012
June 13, 2012
February 2000
April 2000   (final data collection date for primary outcome measure)
Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70) [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Cmax, maximum insulin aspart concentration [ Designated as safety issue: No ]
  • tmax, time to maximum insulin aspart concentration [ Designated as safety issue: No ]
  • t½, terminal elimination half life [ Designated as safety issue: No ]
  • Mean residence time (MRT) [ Designated as safety issue: No ]
  • Area under the curve from time 0 to infinity (0-∞) [ Designated as safety issue: No ]
  • Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 50) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of Biphasic Insulin Aspart 50 and 70 in Japanese Healthy Volunteers
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Healthy
  • Drug: biphasic insulin aspart 50
    A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days
  • Drug: biphasic insulin aspart 70
    A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days
  • Experimental: Treatment period 1
    Interventions:
    • Drug: biphasic insulin aspart 50
    • Drug: biphasic insulin aspart 70
  • Experimental: Treatment period 2
    Interventions:
    • Drug: biphasic insulin aspart 50
    • Drug: biphasic insulin aspart 70
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2000
April 2000   (final data collection date for primary outcome measure)

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
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01620333
BIASP-1164
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Tomio Sasaki Novo Nordisk Pharma Ltd.
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP