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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT01902121

Run by

Mannkind Corporation

People needed

40

Starts

2013-08-01

Expected to finish

2014-08-01

Last updated by the study team

2014-12-12

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

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