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

NCT ID: NCT01902121

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-08-31

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TI 30 units (10 unit + 20 unit

Technosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge

Group Type EXPERIMENTAL

Technosphere® Insulin 10U + 20U

Intervention Type DRUG

Inhaled Insulin

TI 30 units (30 unit cartridge

Technosphere® Insulin 30 units given as one 30 unit cartridge

Group Type EXPERIMENTAL

Technosphere® Insulin 30U

Intervention Type DRUG

Inhaled Insulin

Interventions

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Technosphere® Insulin 10U + 20U

Inhaled Insulin

Intervention Type DRUG

Technosphere® Insulin 30U

Inhaled Insulin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mannkind Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Neptune City, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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MKC-TI-178

Identifier Type: -

Identifier Source: org_study_id