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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neptune City, New Jersey, 07753, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technosphere® Insulin 10U + 20U

Drug

Inhaled Insulin

Technosphere® Insulin 30U

Drug

Inhaled Insulin

Primary outcomes

Area-under-the-serum insulin concentration versus time curve (AUC0-240min

Time frame: 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing

Sponsors and collaborators

Lead sponsor

Mannkind Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2014
First posted: Jul 18, 2013
Registry last updated: Dec 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed