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Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge

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ClinicalTrials.gov Identifier: NCT01902121
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Technosphere® Insulin 10U + 20U Drug: Technosphere® Insulin 30U Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TI 30 units (10 unit + 20 unit
Technosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge
Drug: Technosphere® Insulin 10U + 20U
Inhaled Insulin

Experimental: TI 30 units (30 unit cartridge
Technosphere® Insulin 30 units given as one 30 unit cartridge
Drug: Technosphere® Insulin 30U
Inhaled Insulin




Primary Outcome Measures :
  1. Area-under-the-serum insulin concentration versus time curve (AUC0-240min [ Time Frame: 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
  • No smoking in the past 6 months (including cigarettes, cigars, and pipes)
  • Urine cotinine testing < 100 ng/mL
  • Body mass index < 32 kg/m2
  • Completion of informed consent form

Exclusion Criteria:

  • FBG > 100 mg/dL
  • Clinically significant active or chronic illness
  • History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant chronic lung disease
  • Respiratory tract infection within 4 weeks before screening and between the screening visit and dosing visit
  • Subjects who are experiencing persistent or recurring cough, wheezing, bronchospasm, or dyspnea

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902121


Locations
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United States, New Jersey
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Mannkind Corporation

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Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01902121     History of Changes
Other Study ID Numbers: MKC-TI-178
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs