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Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N

NCT04022304 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-01-30

No results posted yet for this study

Summary

Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects

Conditions

  • Healthy Volunteer

Interventions

BIOLOGICAL

Biocon Insulin N

Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).

BIOLOGICAL

Humulin® N

Humulin® N (human insulin \[recombinant deoxyribonucleic acid origin\] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate.

Sponsors & Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

    collaborator INDUSTRY

  • Biocon Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Grit Andersen · Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9]

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-15
Primary Completion
2019-12-21
Completion
2019-12-27
FDA Drug
Yes

Countries

  • Germany

Study Locations

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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 NCT04022304 on ClinicalTrials.gov