NCT00674050

A Study Designed to Determine if the Drugs Albuterol (Salbutamol) and Fluticasone Have an Effect on the Pharmacokinetics of the Investigational Product Technosphere® Insulin Inhalation Powder in Healthy Volunteers

A Phase 1, Open-Label Study to Investigate the Effect of Albuterol (Salbutamol) and Fluticasone on the Pharmacokinetics of Inhaled Technosphere® Insulin Inhalation Powder in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the effects of inhaled albuterol \& fluticasone on one dose of TI Inhalation Powder. A total of 12 eligible subjects will be enrolled.

Conditions

• Diabetes Mellitus
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Technosphere Insulin (TI) Inhalation Powder	3.0 U of human insulin. 5 or 10 mg or Technosphere Inhalation Powder, containing 15 0r 30 U of insulin.
DRUG	Albuterol (Salbutamol)	2 puff= 200ug total dose
DRUG	Fluticasone	2 puffs= 500ug total dose

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2008-05-07
• Last updated: 2012-06-13

Locations

1 site across 1 country: United Kingdom