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Completed

NCT Number: NCT01620333

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic insulin aspart 50

Drug

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

biphasic insulin aspart 70

Drug

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

Primary outcomes

  1. Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70)

Secondary outcomes

  1. Cmax, maximum insulin aspart concentration

  2. tmax, time to maximum insulin aspart concentration

  3. t½, terminal elimination half life

  4. Mean residence time (MRT)

  5. Area under the curve from time 0 to infinity (0-∞)

  6. Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 50)

  7. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2000
Study completion
2000
First posted
Jun 15, 2012
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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