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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc

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