Trial record 27 of 46 for:    mannkind

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01902121
First received: July 15, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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
Endpoint Classification: Bio-equivalence Study
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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: August 2013
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902121

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

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01902121     History of Changes
Other Study ID Numbers: MKC-TI-178
Study First Received: July 15, 2013
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014