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

NCT01620333 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-01-05

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR,1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-02-29
Primary Completion
2000-04-30
Completion
2000-04-30

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01620333 on ClinicalTrials.gov