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Pharmacokinetic Study in Healthy Volunteers

NCT01365117 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-06-14

No results posted yet for this study

Summary

Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Technosphere® Insulin Inhalation Powder

15 subjects in a three-way crossover (three different doses of TI Inhalation Powder \[one 20 U, two 20 U and one 40 U cartridges)

DRUG

Technosphere® Insulin Inhalation Powder

16 subjects in a four-way crossover (four different doses of TI Inhalation Powder \[one 20 U, one 20 U plus one 10U, one 30 U (3 U per mg), one 30 U (4 U per mg cartridges)\])

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Principal Investigators

  • Sandra Connolly, M.D. · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-02-28
Completion
2011-04-30

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 NCT01365117 on ClinicalTrials.gov