Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/30/2013 |
| Start Date: | August 2013 |
| End Date: | March 2014 |
| Contact: | MannKind Investigational Site |
| Phone: | 6617755300 |
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
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.
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
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