Status:
COMPLETED
Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge
Lead Sponsor:
Mannkind Corporation
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 on...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01902121
Start Date
August 1 2013
End Date
August 1 2014
Last Update
December 12 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Neptune City, New Jersey, United States, 07753