A Phase 1, Open-label, Randomized, Crossover Clinical Trial in Healthy Normal Volunteers to Evaluate the Bioequivalence of 30 U TI Inhalation Powder Delivered by Gen2 Inhaler Using One 30 U Cartridge Versus a Combination of 10 U and 20 U Cartridges
Sponsor study identifier
interventional
40
1 country
1
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2013
Actual (reported)Study Completion
August 2014
Actual (reported)A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 15, 2013
Actual (reported)July 18, 2013
Actual (reported)August 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 2013
Actual (reported)August 2014
Actual (reported)Area-under-the-serum insulin concentration versus time curve (AUC0-240min
0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing
Technosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge
Technosphere® Insulin 30 units given as one 30 unit cartridge
Inhaled Insulin
Inhaled Insulin
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Neptune City, New Jersey, 07753, United States
40 participants (actual enrollment reported by the registry).
First Submitted
July 15, 2013
First Posted
July 18, 2013
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers
Contact the study team to confirm eligibility.
Primary Completion
November 2013
Actual (reported)Study Completion
August 2014
Actual (reported)Last Updated
December 12, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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