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

MannKind

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Technosphere® Insulin 30U

Drug: Technosphere® Insulin 10U + 20U

Study type

Interventional

Funder types

Industry

Identifiers

NCT01902121

MKC-TI-178

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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