Pharmacokinetic Study in Healthy Volunteers

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-04-30

Brief Summary

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Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.

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Detailed Description

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Phase 1, single-center, open-label, randomized, crossover clinical trial to evaluate insulin exposure using the 3 U/mg and 4 U/mg Technosphere Insulin Inhalation Powder formulations administered using the Gen2 inhaler in 31 healthy volunteers. Drop outs will be replaced. Each subject will undergo a screening visit and either 4 or 5 days of in clinic stay and dosing, depending on randomization schedule.

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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Cohort 1

Group Type EXPERIMENTAL

Technosphere® Insulin Inhalation Powder

Intervention Type DRUG

15 subjects in a three-way crossover (three different doses of TI Inhalation Powder \[one 20 U, two 20 U and one 40 U cartridges)

Cohort 2

Group Type EXPERIMENTAL

Technosphere® Insulin Inhalation Powder

Intervention Type DRUG

16 subjects in a four-way crossover (four different doses of TI Inhalation Powder \[one 20 U, one 20 U plus one 10U, one 30 U (3 U per mg), one 30 U (4 U per mg cartridges)\])

Interventions

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Technosphere® Insulin Inhalation Powder

15 subjects in a three-way crossover (three different doses of TI Inhalation Powder \[one 20 U, two 20 U and one 40 U cartridges)

Intervention Type DRUG

Technosphere® Insulin Inhalation Powder

16 subjects in a four-way crossover (four different doses of TI Inhalation Powder \[one 20 U, one 20 U plus one 10U, one 30 U (3 U per mg), one 30 U (4 U per mg cartridges)\])

Intervention Type DRUG

Other Intervention Names

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Inhaled human insulin and Technosphere Powder Inhaled human insulin and Technosphere Powder

Eligibility Criteria

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Inclusion Criteria

* Non-smoking (within the last 6 months) men and women aged 18 to 45 years who are considered healthy
* Body mass index (BMI) \< 32 kg/m2
* FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted

Exclusion Criteria

* Pre-existing asthma or chronic obstructive pulmonary disease (COPD)
* History of coronary artery disease, peripheral vascular disease, or congestive heart failure
* Blood donation within the previous 3 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes