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Trial record 29 of 49 for:    mannkind

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

This study has been completed.
Information provided by (Responsible Party):
Mannkind Corporation Identifier:
First received: July 15, 2013
Last updated: December 11, 2014
Last verified: December 2014
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 Intervention Phase
Healthy Volunteers Drug: Technosphere® Insulin 10U + 20U Drug: Technosphere® Insulin 30U Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: August 2013
Study Completion Date: August 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01902121

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

Responsible Party: Mannkind Corporation Identifier: NCT01902121     History of Changes
Other Study ID Numbers: MKC-TI-178
Study First Received: July 15, 2013
Last Updated: December 11, 2014

Additional relevant MeSH terms:
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on June 23, 2017