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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Technosphere® Insulin 10U + 20U; Drug: Technosphere® Insulin 30U

• Registration Number: NCT01902121
• Lead Sponsor: Mannkind Corporation

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 one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-18
• Study Start: 2013-08
• Primary Completion: 2013-11
• Study Completion: 2014-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TI 30 units (10 unit + 20 unit	Technosphere® Insulin 10U + 20U	Technosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge
TI 30 units (30 unit cartridge	Technosphere® Insulin 30U	Technosphere® Insulin 30 units given as one 30 unit cartridge

Primary Outcome Measures

Name	Time	Method
Area-under-the-serum insulin concentration versus time curve (AUC0-240min	0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing