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 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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01902121

Enrollment

Registered

2013-07-18

Start date

2013-08-31

Completion date

2014-08-31

Last updated

2014-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGTechnosphere® Insulin 10U + 20U

Inhaled Insulin

DRUGTechnosphere® Insulin 30U

Inhaled Insulin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026