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Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Mixture Listro Mix 75/25® and Humalog Mix75/25 ® in Healthy Subjects

NCT01400802 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-01-25

No results posted yet for this study

Summary

The aim of this study is to assess the bioequivalence of two insulin analog mixtures: Listro Mix75/25® and Humalog Mix75/25® in healthy subjects based on the pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).

Conditions

  • Bioequivalence in Healthy Subjects

Interventions

BIOLOGICAL

Insulin Lispro

Dosage form- Subcutaneous Injection

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • United States

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 NCT01400802 on ClinicalTrials.gov