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Bioequivalence of Fresenius Kabi USA, LLC Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories)

NCT02086227 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-03-13

No results posted yet for this study

Summary

The primary objective of this study is to ascertain the pharmacokinetics (PK) and pharmacodynamics (PD) bioequivalence of a subcutaneous (SC) injection of 1 mg (1 IU) of Glucagon (Fresenius Kabi USA) in comparison to the reference product, GlucaGen® (Bedford Laboratories), 1 mg (1 IU), SC in healthy adult subjects.

Conditions

Interventions

DRUG

Glucagon for Injection (Fresenius Kabi USA)

Test product: A 1 mg (1 IU/ml) Glucagon for Injection (Fresenius Kabi USA)

DRUG

Glucagon for Injection (Bedford Laboratories)

Reference product: B 1 mg (1 IU/ml) of GlucaGen® for Injection (Bedford Laboratories)

Sponsors & Collaborators

  • Fresenius Kabi USA, LLC

    lead INDUSTRY

Principal Investigators

  • Oscar De Valle, M.D. · West Houston Clinical Research Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02086227 on ClinicalTrials.gov